FDA-Drug2021-09-29Class II
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
Morton Grove Pharmaceuticals, Inc.
Hazard
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Sold states
Nationwide USA and China
Affected count
14,904 bottles
Manufactured in
6451 Main St, Morton Grove, IL, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0815-2021Don't want to check this manually?
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