Morton Grove Pharmaceuticals, Inc. recalls Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint
Recalled September 29, 2021 · FDA recall D-0815-2021 · Morton Grove Pharmaceuticals
Hazard
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. · FDA Class II
Units
14,904 bottles
Sold at
Nationwide USA and China
Description
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Product
Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-606-16
Manufacturer(s)
Morton Grove Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →