Reported Sep 29, 2021 · Completed
Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1…
Morton Grove Pharmaceuticals, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Morton Grove Pharmaceuticals, Inc. · 6451 Main St · Morton Grove, IL · 60053-2633
Is this the product you have?
- Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only
- Manufactured ForWockhardt USA, LLC, Parsippany, NJ 07054
- Manuractured ByMorton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053
- NDC60432-606-16
- Lot codes and dates
- Lot #: UV1198
- Amount recalled
- 14,904 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
This product could cause temporary or reversible health problems — stop using it.
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