Multi-event February 2015 FDA Recall Drug by Actavis Inc
This Multi-event Class II drug recall was voluntarily initiated by Actavis Inc on February 12, 2015 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0396-2015
Subpotent Drug
02-12-2015
03-11-2015
51,472 cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Actavis Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
12-04-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3560-15
Batch or Lot Expiration Information
Lot# : 310935 Exp 3/31/2015
Lot# : 3109552 Exp 3/31/2015
Lot# : 3110204, Exp 3/31/2015
Lot# : 3112972, Exp 7/31/2015
Lot# : 3114073, Exp 8/31/2015
Lot# : 3115756, Exp 10/31/2015
Lot# : 3115888, Exp 10/31/2015
Lot# : 3118059, Exp 11/30/2015.
Recall Number: D-0406-2015
Subpotent Drug
02-12-2015
03-11-2015
29,405 cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Actavis Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
12-04-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3561-15
Batch or Lot Expiration Information
Lot# : 3109554, Exp 3/31/2015
Lot# : 3111457, Exp 3/31/2015
Lot# : 3112973, Exp 7/31/2015
Lot# : 3114262, Exp 6/30/2015
Lot# : 3114076, Exp 12/31/2015
Lot# : 3115889, Exp 12/31/2015
Lot# : 3116033, Exp 12/31/2015.
