Morton Grove Pharmaceuticals recalls Promethazine With Codeine Oral Solution due to potential microbial contamination in liquid sugar batches. This prescription medication may pose a risk of infection if used. Consumers should contact the manufacturer for details.
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Morton Grove Pharmaceuticals is recalling Promethazine With Codeine Oral Solution (1 pint) because it may contain microbial organisms from contaminated liquid sugar batches. This could lead to infection if the medication is used. The product is prescription-only and sold under NDC 60432-606-16.
The product was manufactured using liquid sugar batches that may have been contaminated with microbial organisms. This contamination could lead to infection if the medication is taken, especially in individuals with weakened immune systems.
Prescription patients who have received this specific Promethazine With Codeine Oral Solution (1 pint) from Morton Grove Pharmaceuticals. Those with compromised immune systems may be at higher risk.
Check for the product name 'Promethazine With Codeine Oral Solution', 1 pint (473 mL), prescription-only, with NDC code 60432-606-16. The lot number UV1198 is also associated with this batch.
Verify the product name, size (1 pint), and NDC code 60432-606-16 to confirm if it is recalled.
The recall indicates potential microbial contamination, so it is not recommended to use this product without contacting the manufacturer first.
Contact Morton Grove Pharmaceuticals directly for specific instructions on what to do with the product.
The recall mentions potential microbial contamination, which could lead to infection, but the record does not specify a risk of serious injury.
We’ve drafted a message you can send Morton Grove Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0815-2021 — Morton Grove Pharmaceuticals Morton Grove Pharmaceuticals Hello, I own a Morton Grove Pharmaceuticals that is covered by recall D-0815-2021 from Morton Grove Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.