May 2017 FDA Recall Famotidine by Lupin Pharmaceuticals Inc.
D-1127-2017 - CGMP Deviations

This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on May 2, 2017 for the product Famotidine. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1127-2017

Reason for Recall
CGMP Deviations
Initiated
05-02-2017
Reported
09-13-2017
Quantity
12,888 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78032
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.
Lupin Pharmaceuticals Inc.
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2018
Product Description About Product Description
Full technical description of the product.
Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA, NDC 68180-150-01

Batch or Lot Expiration Information

Lot# : G606950, Exp 07/18

Affected Packages Involved in this Recall

68180-150-01 Famotidine