Morton Grove Pharmaceuticals recalls Promethazine Syrup Plain (6.25 mg/5mL) due to potential microbial contamination in sugar batches used during manufacturing. This Rx-only syrup, sold in 1 pint containers, may pose health risks if consumed.
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Morton Grove Pharmaceuticals is recalling Promethazine Syrup Plain (6.25 mg/5 mL) because it was manufactured using potentially contaminated sugar batches. This recall affects prescription-only syrup sold in 1 pint containers with specific lot numbers. The risk involves possible microbial contamination that could cause health issues if consumed.
The syrup was produced using liquid sugar batches that may have been contaminated with microbial organisms. This contamination could lead to health issues if the product is consumed, though the exact risk level isn't specified in the recall notice.
Prescription holders of Promethazine Syrup Plain (6.25 mg/5 mL) in 1 pint containers with lot numbers UV1335, UV1352, or UV1373. Patients using this medication for allergies, nausea, or motion sickness are most at risk.
Check for the product name 'Promethazine Syrup Plain', strength 6.25 mg/5 mL, and 1 pint (473 mL) container. Look for lot numbers UV1335, UV1352, or UV1373 on the label.
Identify the lot number on the container to determine if it's affected (UV1335, UV1352, or UV1373).
The recall states there's a potential concern with microbial contamination in sugar batches, but it doesn't specify if the product is safe to use. Consult your healthcare provider for guidance.
The recall does not provide a specific remedy, so contact your healthcare provider for advice on whether to stop using the product.
Check the label for 'Promethazine Syrup Plain', 6.25 mg/5 mL, 1 pint container, and lot numbers UV1335, UV1352, or UV1373.
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-0814-2021 — Morton Grove Pharmaceuticals Morton Grove Pharmaceuticals Hello, I own a Morton Grove Pharmaceuticals that is covered by recall D-0814-2021 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.
