Multi-event August 2012 FDA Recall Drug by Actavis Mid Atlantic Llc

This Multi-event Class III drug recall was voluntarily initiated by Actavis Mid Atlantic Llc on August 14, 2012 for the product Drug. The FDA reported the reason for recall as impurities/degradation products. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-006-2013 TERMINATED D-005-2013 TERMINATED

Recall Number: D-006-2013

Reason for Recall
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Initiated
08-14-2012
Reported
10-17-2012
Quantity
19,980 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62827
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Actavis Mid Atlantic LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide & Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-27-2013
Product Description About Product Description
Full technical description of the 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 0472-1629-16

Batch or Lot Expiration Information

Lot# X110042, X110051, X110064, Exp 09/13

Recall Number: D-005-2013

Reason for Recall
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Initiated
08-14-2012
Reported
10-17-2012
Quantity
14,868 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62827
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Actavis Mid Atlantic LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide & Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-27-2013
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# X111001, X111008, X111030, Exp 10/13