Safety Alerts & Recalls

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Qualitest Recalls One Lot of Hydrocodone Bitartrate and Acetaminophen Tablets
The manufacturer Qualitest has issued a voluntary, nationwide retail level recall for the following: Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg, NDC 0603-3888-21, 100 count, Lot Number C1440512A, expiry date 12/13. It is possible that some tablets from this lot may be oversized and may contain a higher dosage of the ingredients Hydrocodone Bitartrate and Acetaminophen. Taking a higher dosage of acetaminophen than intended could potentially cause severe liver damage, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Taking a higher dose of hydrocodone than intended could result in an increase in the severity or frequency of side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or are also taking interacting medications, for example other sedating medications or certain antidepressants. For more information, please visit: http://www.fda.gov/Safety/Recalls/ucm318827.htm?source=govdelivery
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Sun Pharmaceutical Recalls Select Lots of Nimodipine Capsules
Sun Pharmaceutical Industries, Inc. (Sun Inc.) announced that it is voluntarily recalling select lots of Nimodipine Capsules, 30 mg, marketed by Caraco Pharmaceutical Laboratories, Ltd. Nimodipine capsules are used to decrease problems due to subarachnoid hemorrhage (bleeding in the brain). Sun Inc. issued the recall as a precautionary measure due to the presence of crystals of nimodipine within the capsule solution of this lot. The presence of the crystals could adversely affect the drug levels in a patient who had taken the recalled product which in turn may potentially change the product’s effectiveness or risk of side effects. No adverse events have been reported at this time. However, as a precautionary measure, Sun Inc. is recalling the following lot numbers to minimize any potential risk to patients: Lot Number: 3305.039A, NDC Number: 57664-135-65 (Unit Dose Blisters of 100 (25x4)) Lot Number: 3305.039B, NDC Number: 57664-135-64 (Unit Dose Blisters of 30 (5x6)) For more information, please visit: http://www.fda.gov/Safety/Recalls/ucm318118.htm?source=govdelivery
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Date Published Title Drug Source
2012-09-12 Qualitest Recalls One Lot of Hydrocodone Bitartrate and Acetaminophen Tablets Hydrocodone with Acetaminophen Manufacturer
2012-09-05 Sun Pharmaceutical Recalls Select Lots of Nimodipine Capsules Nimodipine FDA
2012-08-31 FDA recommends against use of Revatio in children with pulmonary hypertension Sildenafil FDA
2012-08-29 Genzyme Recalls Select Lots of Thymoglobulin Manufacturer
2012-08-17 FDA Warns: Codeine May Be Risky for Some Children FDA
2012-08-09 Fougera Pharmaceuticals, Inc. Recalls Single Lot of Erythromycin Topical Solution USP, 2% Erythromycin FDA
2012-08-09 Grandpa Brands Co. Recalls Select Lots of Dent's Extra Strength Toothache Gum Benzocaine FDA
2012-08-09 Vintage Pharmaceuticals Recalls Several Lots of Hydroxyzine Hydrochloride Oral Solutions 10 mg/ 5 mL Hydroxyzine FDA
2012-08-09 Bayer Health Care Recalls Several Lots of Midol Complete Midol FDA
2012-08-09 Alaven Pharmaceutical LLC Recalls Several Lots of Prefera OB One Gel Capsules Prenatal Vitamins FDA
2012-07-25 Qualitest Recalls Several Lots of Hydrocortisone and Acetic Acid Otic Solution FDA
2012-07-25 AstraZeneca Recalls Single Lot of Nexium (esomeprazole magnesium) Delayed-Release Capsules Esomeprazole FDA
2012-07-25 VistaPharm Recalls Select Lot of Hydrocodone Bitartrate & Acetaminophen Oral Solution Hydrocodone with Acetaminophen FDA
2012-07-25 GlaxoSmithKline Recalls Single Lot of Trizivir Tablets Abacavir Sulfate with Lamivudine / Zidovudine FDA
2012-07-25 Noven Pharmaceutical Recalls One More Lot of Daytrana Patches Methylphenidate FDA
2012-07-24 FDA Warns: Abnormal Heart Rhythms May Be Associated with Use of High Dose Zofran (Ondansetron) Ondansetron FDA
2012-07-23 FDA Issues Drug Safety Communication about the Risk of Seizures with Ampyra (Dalfampridine) Dalfampridine FDA
2012-07-23 Teva Pharmaceuticals USA Recalls Several Lots of Zeosa Norethindrone / Ethinyl Estradiol / Ferrous Fumarate FDA
2012-07-23 Teva Pharmaceuticals USA, Inc. Recalls Several Lots of Atenolol Tablets, 25 mg Atenolol FDA
2012-07-22 Physicians Total Care, Inc Recalls Several Lots of Arthrotec 75 Diclofenac Sodium with Misoprostol FDA
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