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
Reported: September 29, 2021 Initiated: September 3, 2021 #D-0815-2021
Product Description
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
Reason for Recall
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Details
- Recalling Firm
- Morton Grove Pharmaceuticals, Inc.
- Units Affected
- 14,904 bottles
- Distribution
- Nationwide USA and China
- Location
- Morton Grove, IL
Frequently Asked Questions
What product 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. Recalled by Morton Grove Pharmaceuticals, Inc.. Units affected: 14,904 bottles.
Why was this product recalled? ▼
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 29, 2021. Severity: Moderate. Recall number: D-0815-2021.
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