The Recall Desk

FDA (Drugs) recall action 62827

Actavis Mid Atlantic LLC recalled 2 products on 2012-10-17

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-10-17
Critical
0
Units
34,848

Why these products were recalled

Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • LowFDA (Drugs)··2012-10-17

    Actavis Recalls Prometh VC Plain Due to Unknown Degradant

    Actavis Mid Atlantic LLC is recalling Prometh VC Plain bottles because they do not meet stability specifications for an unknown degradant.

    Product
    Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic, LLC., 1877 Kawaii Road, Lincolnton, NC, 28092, USA, NDC 0472-1628-16.
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2012-10-17

    Actavis Recalls Prometh VC with Codeine Cough Syrup Due to Stability Issues

    Actavis Mid Atlantic LLC is recalling Prometh VC with Codeine Cough Syrup because specific lots do not meet room temperature stability specifications for an unknown degradant.

    Product
    Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic LLC., 1877 Kawaii Road, Lincolnton, NC 28092 USA, NDC 0
    Category
    Distribution
    1 state