Prometh VC Plain recall: Impurity Out of Spec
Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only…
Why was Prometh VC Plain recalled?
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
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?
X111001, X111008, X111030, Exp 10/13
- Product
- Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only…
- Recalling firm
- Actavis Mid Atlantic LLC
- Quantity
- 14,868 Bottles
- Distribution
- Nationwide & Puerto Rico
- Recall date
- October 17, 2012
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)