July 2017 FDA Recall Famotidine by Teva Pharmaceuticals Usa
D-1056-2017 - Failed Tablet/Capsule Specification; out of specification for tablet weight
This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on July 24, 2017 for the product Famotidine. The FDA reported the reason for recall as failed tablet/capsule specification; out of specification for tablet weight. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1056-2017
Failed Tablet/Capsule Specification; out of specification for tablet weight
07-24-2017
08-09-2017
28,188 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.
Teva Pharmaceuticals USA
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
01-31-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-5728-60
Batch or Lot Expiration Information
Lot# 3429066, exp 06/2018
