Reported Oct 17, 2012 · Terminated
Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg;…
Actavis Mid Atlantic LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Actavis Mid Atlantic LLC · 1877 Kawai Rd · Lincolnton, NC · 28092-5905
Is this the product you have?
- Prometh VC with Codeine Cough Syrup, CV
- Each 5mL contains
Codeine phosphate 10mgpromethazine hydrochloride 6.25mgphenylephrine hydrochloride 5mgOne Pint Bottles (473mL)Rx Only
- Manufactured by
Actavis Mid Atlantic LLC1877 Kawaii RoadLincolntonNC 28092 USANDC 0472-1629-16
- Lot codes and dates
X110042X110051X110064Exp 09/13
- Amount recalled
- 19,980 Bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Actavis Mid Atlantic LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.