Class I - Dangerous
Labeling: Label Error on Declared Strength
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Prescription Drugs
💊 Drugs • 12,141 recalls
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 .
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.
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 .
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
Class I - Dangerous
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Class I - Dangerous
Labeling: Missing label: Label missing from some prefilled pens.
Class I - Dangerous
FAILED DISSOLUTION SPECIFICATIONS
Presence of particulate matter: particulate identified as a beetle.
Class I - Dangerous
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704
Valor Compounding Pharmacy, Inc
Class I - Dangerous
Subpotent and Superpotent Drug
Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-447-90
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
Failed Dissolution Specifications
Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
Failed dissolution specifications.