Reported Oct 17, 2012 · Terminated
Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint…
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 Plain
- Each 5mL containsPromethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only
- Manufactured byActavis Mid Atlantic, LLC., 1877 Kawaii Road, Lincolnton, NC, 28092, USA, NDC 0472-1628-16
- Lot codes and dates
X111001X111008X111030Exp 10/13
- Amount recalled
- 14,868 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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