May 2014 FDA Recall Promethazine Hydrochloride by Zydus Pharmaceuticals Usa Inc
D-1342-2014 - Presence of Foreign Tablets
This Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals Usa Inc on May 8, 2014 for the product Promethazine Hydrochloride. The FDA reported the reason for recall as presence of foreign tablets. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1342-2014
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
05-08-2014
05-28-2014
10,200 bottles
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.
Zydus Pharmaceuticals USA 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
02-26-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01
Batch or Lot Expiration Information
Lot# : MN9081, Expiry: 09/2015
