FDA Drug Recalls

January 7, 2020 · DrugView 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 LLC

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

January 6, 2020 · DrugView details →

Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60

H J Harkins Company Inc dba Pharma Pac

CGMP Deviations: Presence of NDMA impurity detected in product.

Class ITerminated

Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 NDC 70518-1239-00

RemedyRepack Inc.

Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.

December 27, 2019 · DrugView details →

Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ

Sun Pharmaceutical Industries, Inc.

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

Class IIITerminated

Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12

Akorn, Inc.

Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample

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

AAA Pharmaceutical, Inc.

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

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

AAA Pharmaceutical, Inc.

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

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 Inc.

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

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, Inc.

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

December 23, 2019 · DrugView details →

Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059. NDC carton: 0067-6089-01, NDC packet: 0067-6089-03

GSK Consumer Health, Inc

Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, Ask a doctor before use if you have a sodium-restricted diet.

LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial Assurance Infusion (713) 533-8800

Assurance Infusion

Lack of sterility assurance.

BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion

Lack of sterility assurance.

Class ITerminated

Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.

Taro Pharmaceuticals U.S.A., Inc.

Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.

BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion

Lack of sterility assurance.

HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion

Lack of sterility assurance.

HYDROM 1MG/MORP 20MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion

Lack of sterility assurance.

BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion

Lack of sterility assurance.

BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion

Lack of sterility assurance.

BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion

Lack of sterility assurance.

BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Assurance Infusion

Lack of sterility assurance.