Promethazine With Codeine Oral Solution recalled over manufacturing violations

Recall date

September 3, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Morton Grove Pharmaceuticals, Inc. recalls Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pin…

Recall number

D-0815-2021

FDA classification

Class II

Brand / firm

Morton Grove Pharmaceuticals, Inc.

Sold / distributed

Nationwide USA and China

Why it was recalled

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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