Promethazine Syrup Plain recall: CGMP Deviations
Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC…
Why was Promethazine Syrup Plain 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 #: UV1335; UV1352; and UV1373
- Product
- Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC…
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
- Quantity
- 116,400 bottles
- Distribution
- Nationwide USA and China
- Recall date
- September 29, 2021
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (drug)