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Prescription Drugs

💊 Drugs • 11,927 recalls

Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blister card (NDC 62756-521-69) and b) 100 count bottles, (NDC 62756-521-88), Rx only, Sun Pharma, Cranbury, NJ

Sun Pharmaceutical Industries

Class I - Dangerous

Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.

Dec 26, 2019 Prescription Drugs View Details →

Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial (NDC 62756-015-40) and b) 10 mL Multiple Dose Vial (NDC 62756-016-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India

Sun Pharmaceutical Industries

Class I - Dangerous

cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.

Jan 14, 2020 Prescription Drugs View Details →

Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-20

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Dec 17, 2019 Prescription Drugs View Details →

Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Dec 17, 2019 Prescription Drugs View Details →

Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.

Appco Pharma

Class I - Dangerous

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Jan 7, 2020 Prescription Drugs View Details →

Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Dec 17, 2019 Prescription Drugs View Details →

Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-05

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Dec 17, 2019 Prescription Drugs View Details →

Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.

AAA Pharmaceutical

Class I - Dangerous

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Dec 26, 2019 Prescription Drugs View Details →

Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.

AAA Pharmaceutical

Class I - Dangerous

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Dec 26, 2019 Prescription Drugs View Details →

Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-01

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Dec 17, 2019 Prescription Drugs View Details →

Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Dec 17, 2019 Prescription Drugs View Details →

Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for: Lupin Limited Pithampur 454775 INDIA 240875, NDC 68180-866-11

Lupin Pharmaceuticals

Class I - Dangerous

Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.

Dec 26, 2019 Prescription Drugs Nationwide View Details →

Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.

Appco Pharma

Class I - Dangerous

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Jan 7, 2020 Prescription Drugs View Details →

RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32

Granules India Limited

Class I - Dangerous

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Dec 13, 2019 Prescription Drugs View Details →

Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.

Lupin Pharmaceuticals

Class I - Dangerous

Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.

Dec 13, 2019 Prescription Drugs Nationwide View Details →

MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forset, IL 60045; NDC 61748-302-13.

Akorn

Class I - Dangerous

Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.

Nov 15, 2019 Prescription Drugs Nationwide View Details →

Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 male enhancement capsules in blister foil package, 725mg per capsule, Distributed by Silver Bullet Ltd, Golden Springs, CO, USA, UPC: 610877392698.

Natures Rx

Class I - Dangerous

Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.

Nov 13, 2019 Prescription Drugs Nationwide View Details →

Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)

American Health Packaging

Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Nov 1, 2019 Prescription Drugs Nationwide View Details →

NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.

Pharmedium Services

Class I - Dangerous

Subpotent Drug

Dec 16, 2019 Prescription Drugs Nationwide View Details →

NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.

Pharmedium Services

Class I - Dangerous

Subpotent Drug

Dec 16, 2019 Prescription Drugs Nationwide View Details →

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