January 2019 FDA Recall Cephalexin by Lupin Pharmaceuticals Inc. (D-0423-2019 - CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.)

This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on January 9, 2019 for the product Cephalexin. The FDA reported the reason for recall as cgmp deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.. The product was distributed in Product was distributed to 5 wholesalers, 2 drug chains and 1 supermarket who may have further distributed the product throughout the United States. and the recall is currently terminated.

Recall Number: D-0423-2019

Reason for Recall
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
Initiated
01-09-2019
Reported
02-06-2019
Quantity
14,400 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81908
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 5 wholesalers, 2 drug chains and 1 supermarket who may have further distributed the product throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-08-2020
Product Description About Product Description
Full technical description of the product.
Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01

Batch or Lot Expiration Information

Lot# lot F801282, Expiry June 2020

Affected Packages Involved in this Recall

68180-123-01 Cephalexin
68180-123-02 Cephalexin
68180-124-01 Cephalexin
68180-124-02 Cephalexin
68180-440-01 Cephalexin
68180-440-02 Cephalexin
68180-441-01 Cephalexin
68180-441-02 Cephalexin