FDAClass IIIOctober 17, 2012

Prometh VC with Codeine Cough Syrup recall: Impurity Out of Spec

Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride…

Why was Prometh VC with Codeine Cough Syrup 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?

X110042, X110051, X110064, Exp 09/13

Product
Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride…
Recalling firm
Actavis Mid Atlantic LLC
Quantity
19,980 Bottles
Distribution
Nationwide & Puerto Rico
Recall date
October 17, 2012
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls