Class III
Terminated
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
- Company
- Aidarex Pharmaceuticals Llc
- Recall Initiated
- June 1, 2016
- Posted
- June 15, 2016
- Recall Number
- D-0974-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 10
- Firm Location
- Corona, CA, United States
Reason for Recall
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Distribution
IN, GA
Lot / Code Info
Lot#: 47312-1, Exp 01/2018
More recalls by Aidarex Pharmaceuticals Llc
Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Woc...
Aug 1, 2018 · Class III
Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00
May 23, 2018 · Class III
ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged...
Nov 1, 2017 · Class III
Other recent Class III Drug recalls
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Via...
Slate Run Pharmaceuticals
· Mar 4, 2026
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceutica...
Unichem Pharmaceuticals Usa Inc.
· Feb 18, 2026
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL),...
Haleon Us Holdings Llc
· Feb 4, 2026
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceutic...
Novadoz Pharmaceuticals Llc
· Feb 4, 2026
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd.,...
Cipla Usa, Inc.
· Jan 28, 2026