🍔 Food 💊 Drugs 🏥 Medical Devices
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01 Class II

Reason: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Hikma Pharmaceuticals USA Inc. 20220711 Terminated
Distributed: Nationwide in the USA
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Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01 Class II

Reason: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Hikma Pharmaceuticals USA Inc. 20220711 Terminated
Distributed: Nationwide in the USA
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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 Class II

Reason: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Hikma Pharmaceuticals USA Inc. 20220711 Terminated
Distributed: Nationwide in the USA
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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. Class II

Reason: Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .

Glenmark Pharmaceuticals Inc., USA 20220629 Terminated
Distributed: nationwide
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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. Class II

Reason: Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .

Glenmark Pharmaceuticals Inc., USA 20220629 Terminated
Distributed: nationwide
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SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9. Class I

Reason: Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.

Ultra Supplement LLC 20220721 Terminated
Distributed: Product was distributed nationwide in the USA via Amazon Marketplace on www.amazon.com.
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SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC, (800) 519-0204 Miami 33172 FL, USA; UPC 0 705632 523285 Class I

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.

Distributor RFR, LLC. 20220722 Terminated
Distributed: Retail stores in the state of FL, Nationwide in the USA, France and Canada via website sales, and Bolivarian Republic of Venezuela
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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. Class III

Reason: Defective Container: Tube split from side seam

Glenmark Pharmaceuticals Inc., USA 20220711 Ongoing
Distributed: Nationwide in the USA
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Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054 USA; NDC 58544-692-30. Class II

Reason: Failed Dissolution Specifications: below specification limits for dissolution.

Teva Pharmaceuticals USA Inc 20220721 Terminated
Distributed: Nationwide in the USA and Puerto Rico
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Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA; NDC 52544-691-30. Class II

Reason: Failed Dissolution Specifications: below specification limits for dissolution.

Teva Pharmaceuticals USA Inc 20220721 Terminated
Distributed: Nationwide in the USA and Puerto Rico
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