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Recalls and Withdrawals

See withdrawal and/or recall information about:

• Norgestimate and Ethinyl Estradiol Tablets Recall – Packaging Error
• Lo/Ovral® -28 (Norgestrel/Ethinyl Estradiol) Tablets Recall
• Qualitest Pharmaceuticals Voluntary Recall of Oral Contraceptives
• Endo Pharmaceuticals Voluntary Recall of 2 Lots of Endocet® (oxycodone/acetaminophen)
• Voluntary Recall of Coumadin® 5 mg Tablets by Bristol-Myers Squibb
• Greenstone Voluntary Recall of Citalopram and Finasteride – Possible Mislabeling
• Qualitest Pharmaceuticals Voluntary Recall of Hydrocodone Bitartrate and Acetaminophen Tablets
• Ritedose Corporation Voluntary Recall of Albuterol Sulfate Inhalation Solution
• Abbott Glucose Test Strip Recall
• FDA recommends against continued use of propoxyphene
• All 50mg/2ml and 250mg/10ml vials of Methotrexate InjectionRecalled
• Class I Recall: Excelsior Medical Recall of 5 ml Fill in 6 cc Prefilled Saline Flush Syringes
• Lipitor Recall Information
• Batches of Epogen and Procrit Recalled
• Stolen Advair Diskus Alert
• Infant's and Children's OTC Tylenol®, Motrin®, Zyrtec®, and Benadryl® Products Recall
• One touch® Sure Step® test strips
• Voluntary Recall of Fentanyl Transdermal System 25 mcg/hour
• Voluntary Recall of Four PediaCare® Children’s Products
• Accusure Recall

Norgestimate and Ethinyl Estradiol Tablets Recall – Packaging Error, Potential for Incorrect Dosing Regimen

Glenmark Generics Inc. issued a nationwide, consumer-level recall of 7 lots of Norgestimate and Ethinyl Estradiol tablets USP (0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg) because of a packaging error: Select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date visible only on the outer pouch. As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect. This could leave women without adequate contraception and at risk for unintended pregnancy.

Consumers exposed to affected packaging should begin using a nonhormonal form of contraception immediately. Patients who have the affected product should notify their physician and return the product to the pharmacy.

Lot numbers are as follows for affected packs of Norgestimate and Ethinyl Estradiol tablets USP, 0.18 mg/0.035mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg (generics):

For more information about this recall, please visit the FDA website.

Lo/Ovral®-28 (Norgestrel/Ethinyl Estradiol) Tablets Recall — Possibility of Inexact Tablet Counts or Out of Sequence Tablets

Pfizer Inc. notified health care professionals and consumers that it voluntarily recalled 14 lots of Lo/Ovral®-28 (norgestrel and ethinyl estradiol) Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic) for customers in the U.S. market. An investigation by Pfizer found that some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence. As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.

Patients who have the affected product should notify their physician and return the product to the pharmacy. See Table 1 for a list of affected lot numbers.

Table 1. Lot numbers of affected packs of Lo/Ovral®-28 (norgestrel and ethinyl estradiol) Tablets and Norgestrel and Ethinyl Estradiol Tablets (generic)

Patients who have the affected product should notify their physician and return the product to the pharmacy.

For more detailed information, please read the FDA MedWatch safety alert.

Qualitest Pharmaceuticals Issues a Nationwide Voluntary Recall of Oral Contraceptives

Qualitest Pharmaceuticals issued a voluntary recall of multiple lots of oral contraceptives. The recall is being implemented because of a packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible.  This packaging error and the potential for this error to have affected other oral contraceptive products resulted in the company issuing the recall of multiple lots. 

As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.  These packaging defects do not pose any immediate health risks.  However, consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately and consult their health care provider or pharmacist. 

The recall is effective immediately and includes the following products:
• Cyclafem™ 7/7/7
• Cyclafem™ 1/35
• Emoquette™
• Gildess® FE  1.5/30
• Gildess® FE 1/20
• Orsythia™
• Previfem®
• Tri-Previfem®

The affected lot numbers can be found at the following URL: http://www.qualitestrx.com/pdf/OCRecall.pdf.

Doctors, pharmacists or women seeking additional information on this recall, or consumers who have affected products, should contact Qualitest at 1-877-300-6153, 8:00 a.m. to 5:00 p.m. CT Monday through Friday for information or to arrange return of any affected product.  The lot numbers can be found on the bottom of the box or the individual blister card.

Adverse reactions or quality problems experienced with the use of these products may be reported to Qualitest at 1-877-300-6153 or to the FDA’s MedWatch Adverse Event Reporting program either online (www.fda.gov/medwatch/report.htm ), by regular mail  (mail to address on the pre-addressed form)or by fax (1-800-FDA-0178).

Endo Pharmaceuticals Issues Voluntary Recall of Two Lots of Endocet® (oxycodone/acetaminophen 10/325 mg)

Endo Pharmaceuticals issued a voluntary recall of Endocet® (oxycodone/acetaminophen 10/325 mg, NDC 60951-712-70, lot # 402415NV and # 402426NV).  One bottle from each lot of Endocet® 10/325 mg was found to contain some Endocet® 10 mg/650 mg tablets, which are identifiable by their larger size, and different shape and markings.  Currently, no other bottles from the subject lots or any other lots have been found to erroneously contain Endocet® 10 mg/650 mg tablets.
Due to the recalled bottles containing incorrect tablets that have a higher dosage of acetaminophen, consumers may take more than the intended acetaminophen dose.  Unintentional administration of tablets with increased acetaminophen content may result in liver toxicity; especially in patients on other acetaminophen contain medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day.  The product label warns consumers that acetaminophen overdosage can potentially cause severe liver damage.
The recall includes the following lots of this product:

• Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg 100 count bottles, NDC 60951-712-70, Lot # 402415NV, Expiry 01/2014; and
• Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg 100 count bottles, NDC 60951-712-70, Lot # 402426NV, Expiry 01/2014

Consumers who have the affected product should stop using the product and contact Endo’s agent Stericycle at 1-866-723-2681 for return of the product.  If consumers have any questions as to whether they possess the affected product, please call the number listed above during the hours of 8 a.m. to 8 p.m. EST Monday through Friday and 8 a.m. to 5 p.m. EST Saturday and Sunday

Voluntary Recall of Coumadin® 5 mg Tablets initiated by Bristol-Myers Squibb

Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000 count bottles of Coumadin® (warfarin sodium tablets, USP) 5 mg tablets.  The lot number affected is 9H49374A with an expiry date of September 30th, 2012.  The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle.  A single tablet was found to be higher in potency than expected.

Patients who may have 5 mg tablets should not interrupt their therapy but should seek advice from their pharmacist to see if they have tablets originating from the affected lot and if so, should consult their physician for appropriate medical advice.

Health care professionals and customers may call Stericycle, Inc. at 1-866-918-8739 for assistance or report any adverse reactions to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov

Greenstone Announces Voluntary Nationwide Recall of Citalopram and Finasteride Due to Possible Mislabeling

Greenstone LLC announced a voluntary recall of one lot (lot number F10510058-A) of Citalopram 10 mg tablets, 100-count bottles(used to treat depression) and Finasteride 5 mg tablets ,90-count bottles (used to treat benign prostatic hyperplasia) due to the possibility that incorrect labels have been placed on the bottles. 

Bottles labeled as Citalopram Lot # F10510058-A may contain Finasteride.  Patients who believe they may have ingested the wrong medication should contact their physician as soon as possible.  Women who are, or may become pregnant, should not take or handle Finasteride due to the possible risk of side effects which may cause abnormalities to the external genitalia of a developing male fetus.  Citalopram is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or pimozide.  Patients who discontinue Citalopram abruptly by inadvertently taking the mislabeled product may experience discontinuation symptoms and/or worsening of depression.

Bottles of either Citalopram or Finasteride with lot number F10510058-A should be returned to the pharmacist.

Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.  Also, any adverse events that may be related to the use of these products should be reported to Pfizer Inc. at 1-800-438-1985 (24 hours a day) or to FDA’s Med Watch Program either by www.fda.gov/medwatch/report.htm or by regular mail (postage-paid, pre-addressed form available at www.fda.gov/MedWatch/getforms.htm)  or by fax at 1-800-FDA-0178.

Find more information about this recall on FDA’s website: http://www.fda.gov/Safety/Recalls/ucm248552.htm

Qualitest Pharmaceuticals Issues Voluntary, Nationwide Recall of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg and Phenobarbital Tablets, USP 32.4 mg

Qualitest Pharmaceuticals announced a voluntary nationwide recall of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg/500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E, and T023M10A, and Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot numbers T 150G10B, T120J10E, and T023M10A.  An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg, NDC 0603-3888-20, 60 count, was found incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count label, printed with Lot Number T150G10B. Lots T120J10E and T023M10A used the same stock inventor of labels as Lot T150G10B and are potentially impacted.

As a result of this mix-up, patients may unintentionally take Hydrocodone and Acetaminophen tablets, instead of the intended dose of Phenobarbital.  Unintentional administration of Hydrocodone can result in serious adverse events including respiratory depression, CNS depression, coma and death, especially in opioid naïve patients and patients on other CNS depressants.  Unintentionally administration of acetaminophen may result in liver toxicity in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day.  Additionally, missing doses of Phenobarbital could result in loss of seizure control.

The recall includes the following products:

1. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg, NDC 00603-3888-20, 60 count, Lot Numbers T 150G10B, T120J10E, and T023M10A
2. Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E, and T023M10A

Consumers who have affected product should stop using the product and contact Qualitest at 1-800-444-4011 for reimbursement. For more information regarding this recall, please contact Qualitest at 1-800-444-4011 or visit U.S. Food and Drug Administration webpage at http://www.fda.gov/Safety/Recalls/ucm242398.htm

Ritedose Corporation Announces the Voluntary Recall of 0.083% Albuterol Sulfate Inhalation Solution

The Ritedose Corporation is conducting a voluntary recall of 0.083% Albuterol Sulfate Inhalation Solution, 3 mL (in 25, 30 and 60 unit dose vials).  This product is being recalled because the 2.5 mg/3 mL single use vials are embossed with the wrong concentration of 0.5 mg/3 mL .  The following lot numbers manufactured by The Ritedose Corporation under NDC: 0591-3797-83, 0591-3797-30, and
0591-3797-60 are included in the recall: 0N81, 0N82, 0N83, 0N84, 0NE7, 0NE8, 0NE9, 0NF0, 0P12, 0P13, 0P46, 0P47, 0PF0, and 0S15. 

Administration of this defective product could result in a range of potential health effects.  Significant overdosing of a patient could lead to signs and symptoms of albuterol toxicity, which includes tremors, dizziness, nervousness, headache, seizures, angina, high blood pressure, low potassium levels, and rapid heart rates up to 200 beats/minute.

Consumers should immediately return the affected product to the place it was obtained (i.e. doctor’s office, pharmacy, etc). 

For more information concerning this recall, please contact the Ritedose Corporation at 1-803-935-3995 (Monday through Friday 8 a.m. to 5 p.m. EST) or by email: recall@ritedose.com

Abbott Glucose Test Strip Recall

Abbott Diabetes Care announces to recall 359 different lots of glucose test strips due to a defect that may result in falsely low blood glucose results.  False result may lead patients to try to raise their blood glucose unnecessarily, or to fail to treat elevated blood glucose due to a falsely low reading.  The recalled test strips are marketed under the following brand names including Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, Optium EZ, and ReliOn Ultima.  
Test strips from a recalled lot should not be used and consumers should immediately be switched to test strips from an unaffected lot.  Abbott will replace recalled test strips at no charge.   To determine if you have test strips being recalled or have questions about this recall, please visit www.precisionoptiuminfo.com to look up test strip lot numbers, or call Abbott Diabetes Care customer service at 1-800-448-5234 (English) and 1-800-709-7010 (Spanish).

U.S. Food and Drug Administration (FDA) recommends against continued use of propoxyphene

The U.S. FDA recommends against the continued use of the pain reliever propoxyphene because new data shows the drug can cause serious toxicity to the heart, even when used at therapeutic doses. FDA has asked manufacturers to voluntarily withdraw propoxyphene from the market.

Information for Patients:

If you currently take propoxyphene-containing products, you should:

• Talk to your doctor about discontinuing propoxyphene and switching to alternative pain medicines or if you have any concerns about propoxyphene.
• Contact your doctor right away if you experience an abnormal heart rate or other symptoms including dizziness, lightheadedness, fainting, or fast heartbeat.

Find more information at the FDA’s website.

All 50mg/2ml and 250mg/10ml vials of Methotrexate Injection Recalled

Sandoz Inc.  announced its voluntary recall of all lots of Sandoz and Parenta brand Methotrexate Injection 50 mg/2 mL and 250 mg/10 mL vials.  The vials are being recalled because they may contain small glass flakes.  There is a small risk that severe adverse events including disability and death could occur if a patient is injected with methotrexate from an affected lot.  Potential adverse events could include localized pain and inflammation, damage to blood vessels and neurologic damage.  Patients should contact their physician or healthcare provider if they experience any problem that might be associated with the use of this product.

For more information about this recall, please contact the toll-free Methotrexate recall hotline at 1-888-896-4565 or visit the company's web site at www.us.sandoz.com.

Class I Recall: Excelsior Medical Recall of 5 ml Fill in 6 cc Prefilled Saline Flush Syringes

Excelsior Medical Corporation announced a nationwide recall of Excelsior Disposable 5 ml fill in 6 cc Prefilled Saline Flush Syringe with Normal Saline (0.9% Sodium Chloride). FDA has classified this action as a Class I recall, which is the most serious type of recall.

Excelsior Medical Corporation's routine internal testing found that some of these syringes may leak and lose sterility. Exposure to the leaking syringes could cause systemic infections, which may lead to serious injury or death.

This recall only affects the 5 ml fill in 6 cc prefilled saline flush syringes with the following product code numbers: E011-50, 10056-1000, 10056-240, 14056-240, 910056-1000, and S5. The product code number can be found in the barcode on each syringe and on the carton label.

No other Excelsior Medical prefilled saline syringe product codes are affected by this recall.

For more information, please contact Excelsior Medical Corporation at 1-800-487-4276 or visit the Excelsior Medical web site.

Lipitor Recall Information

Pfizer recalled specific batches of Lipitor (40 mg only) due to a small number of reports of an uncharacteristic odor. A medical assessment has shown that the odor is not likely to pose any health risks in patients taking Lipitor.

If you take Lipitor 40 mg and experience an uncharacteristic odor associated with your medication, please return the tablets to your pharmacist.

If you have any questions about the recall or specific batches of Lipitor 40 mg, please call 1-888-LIPITOR or visit the Lipitor web site.

Batches of Epogen and Procrit Recalled

Amgen announced that certain lots of EPOGEN® and PROCRIT®(Epoetin alfa) vials are being voluntarily recalled because they may contain extremely thin glass flakes (lamellae).

The affected product lot numbers and expiration dates can be found at www.epogen.com and www.procrit.com.

Members with questions regarding this recall can call Amgen for Epogen at 1-800-772-6436 or Centocor Ortho Biotech for Procrit at 1-800-547-6446.

Stolen Advair Diskus Alert

The Food and Drug Administration (FDA) and GlaxoSmithKline issued a safety alert warning that supplies of stolen Advair Diskus® in 2009 have been found in some pharmacies. The stolen Advair Diskus may be harmful because of improper storage that may result in losing potency.

Patients who have products with the lot numbers listed in the following table should stop using them immediately, contact GlaxoSmithKline’s Customer Response Center at 1-888-825-5249 ,and follow up with their physician or pharmacist to obtain a proper replacement.

Lot numbers and doses of the stolen Advair Diskus inhalers