Antibiotic Recalls

Recalls of antibiotics used to treat bacterial infections.

192 recalls in this category, newest first.

Class III · Low risk Terminated Mar 15, 2019

Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA…

Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the…

Pfizer Inc. NDC 47781-621-94 D-1072-2019

Class III · Low risk Terminated Mar 15, 2019

Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058…

Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the…

Pfizer Inc. NDC 47781-620-94 D-1071-2019

Class III · Low risk Terminated Mar 15, 2019

Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058…

Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the…

Pfizer Inc. NDC 47781-619-94 D-1070-2019

Class III · Low risk Terminated Mar 15, 2019

Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by Pharmacia & Upjohn…

Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the…

Pfizer Inc. NDC 0009-3447-01 D-1069-2019

Class III · Low risk Terminated Mar 15, 2019

Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn…

Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the…

Pfizer Inc. NDC 0009-3124-01 D-1068-2019

Class III · Low risk Terminated Mar 15, 2019

Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn…

Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the…

Pfizer Inc. NDC 0009-6582-02 D-1067-2019

Class II · Moderate risk Terminated Jan 9, 2019

Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland…

Reason CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary…

Lupin Pharmaceuticals Inc. NDC 68180-441-01 D-0423-2019

Class II · Moderate risk Terminated Jan 7, 2019

Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc…

Reason CGMP Deviation; manufacturing batch record could not be located

Lupin Pharmaceuticals Inc. NDC 68180-0124-02 D-0380-2019

Class III · Low risk Terminated Oct 29, 2018

Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by…

Reason Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities

Akorn, Inc. NDC 61748-0201-60 D-1208-2019

Class II · Moderate risk Terminated Aug 7, 2018

Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-count bottles, NDC 55289-866-06…

Reason Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.

PD-Rx Pharmaceuticals, Inc. NDC 55289-866-02 D-1127-2018

Class II · Moderate risk Terminated Aug 1, 2018

Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American…

Reason Failed Dissolution Specifications: Out of specification result for the dissolution test.

American Health Packaging D-1582-2019

Class II · Moderate risk Terminated Jul 30, 2018

Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals…

Reason Failed Dissolution Specifications

Major Pharmaceuticals D-1026-2018

Class II · Moderate risk Terminated Jul 24, 2018

Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown…

Reason Failed Dissolution Specifications:

West-Ward Columbus Inc NDC 0143-2112-05 D-1025-2018

Class II · Moderate risk Terminated Jul 24, 2018

Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown…

Reason Failed Dissolution Specifications:

West-Ward Columbus Inc NDC 0143-2112-50 D-1024-2018

Class II · Moderate risk Terminated Apr 24, 2018

Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct for: Lannett Co. Inc., Philadelphia, PA 19136. Mnfct…

Reason Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original…

Prescript Pharmaceuticals, Inc. D-0808-2018

Class II · Moderate risk Terminated Apr 24, 2018

Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannett Co. Inc., Philadelphia, PA. Mnfct for: Lannett Co…

Reason Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original…

Prescript Pharmaceuticals, Inc. D-0805-2018

Class II · Moderate risk Terminated Apr 3, 2018

Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply

Reason Lack of Processing Controls.

Kroger Specialty Pharmacy, Inc. NDC 50111-0787-66 D-0754-2018

Class II · Moderate risk Terminated Feb 9, 2018

Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC 58597-8082-4); b) 100g (NDC 58597-8082-6); c) 500g…

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…

American Pharmaceutical Ingredients LLC NDC 58597-8082-4 D-0486-2018

Class II · Moderate risk Terminated Feb 9, 2018

Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (NDC 58597-8198-3); b) 100g (NDC 58597-8198-6), RX…

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…

American Pharmaceutical Ingredients LLC NDC 58597-8198-3 D-0479-2018

Class III · Low risk Terminated Nov 28, 2017

Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In…

Reason Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.

Teva Pharmaceuticals USA NDC 0093-4125-73 D-0108-2018

Class III · Low risk Terminated Nov 6, 2017

Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag…

Reason Superpotent

Claris Lifesciences Inc NDC 36000-008-24 D-0127-2018

Class II · Moderate risk Terminated Aug 10, 2017

Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle, Rx…

Reason Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.

Morton Grove Pharmaceuticals, Inc. NDC 60432-065-00 D-1125-2017

Class II · Moderate risk Terminated Jun 16, 2017

Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc…

Reason Lack of Assurance of Sterility

Alvogen, Inc NDC 47781-464-69 D-0941-2017

Class II · Moderate risk Terminated Jun 16, 2017

Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc…

Reason Lack of Assurance of Sterility

Alvogen, Inc NDC 47781-463-69 D-0940-2017

Class II · Moderate risk Terminated Jun 16, 2017

Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc…

Reason Lack of Assurance of Sterility

Alvogen, Inc NDC 47781-462-69 D-0939-2017

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