FDAFDA · Food and drugs·Recall number D-0815-2021
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
Published September 29, 2021 · Recall initiated: September 3, 2021
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Morton Grove Pharmaceuticals, Inc.
- Distributor
- Nationwide USA and China
- Lot
- Lot #: UV1198
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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