January 2019 FDA Recall Drug by Lupin Pharmaceuticals Inc.
D-0380-2019 - CGMP Deviation; manufacturing batch record could not be located

This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on January 7, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviation; manufacturing batch record could not be located. The product was distributed in Product was distributed to 12 major distributors who may have further distributed the product throughout the United States. and the recall is currently terminated.

Recall Number: D-0380-2019

Reason for Recall
CGMP Deviation; manufacturing batch record could not be located
Initiated
01-07-2019
Reported
01-23-2019
Quantity
7,215 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81898
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 12 major distributors who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-08-2020
Product Description About Product Description
Full technical description of the product.
Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02

Batch or Lot Expiration Information

Lot# F602820, Expiry December 2019