Class I - Dangerous
Lack of Assurance of Sterility: Complaints received of defective container closure.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Labeling: Label Error on Declared Strength
Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430, NDC 68462-842-13.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0.5 FL OZ) bottle per box, Alcon, a Novartis company, NDC 0065-0085-15.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Class I - Dangerous
Lack of Assurance of Sterility
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6044-25, Vial NDC# 0641-6044-01
Hikma Pharmaceuticals USA
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) bottle per box, Alcon, NDC 0065-1433-02.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc,m USA, Mahwah, NJ 07430, NDC 68462-841-13.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Defective Container: Tube split from side seam
Class I - Dangerous
Failed Dissolution Specifications: below specification limits for dissolution.
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.
Class I - Dangerous
Failed Dissolution Specifications: below specification limits for dissolution.
SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.
Ultra Supplement
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
Class I - Dangerous
FAILED DISSOLUTION SPECIFICATIONS