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FDASeptember 3, 2021drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Completed

Brands named

morton grove pharmaceuticalsmortonmorton grove

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear