Promethazine With Codeine Oral Solution recall: CGMP Deviations
Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only…
Why was Promethazine With Codeine Oral Solution recalled?
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: UV1198
- Product
- Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only…
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
- Quantity
- 14,904 bottles
- Distribution
- Nationwide USA and China
- Recall date
- September 29, 2021
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (drug)