Multi-event November 2019 FDA Recall Cefdinir by Lupin Pharmaceuticals Inc.
This Multi-event Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on November 1, 2019 for the product Cefdinir. The FDA reported the reason for recall as presence of foreign substance. The product was distributed in Product was distributed to major distributors/wholesalers throughout the United States. and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0304-2020
Presence of Foreign substance: identified as a dead ant.
11-01-2019
11-13-2019
28,254 bottles
Recall Profile & Regulatory Data
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.
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.
Lupin Pharmaceuticals 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.
Product was distributed to major distributors/wholesalers throughout the United States.
03-04-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02
Batch or Lot Expiration Information
Lot# : F802436, F802437, F802438, F802442, Exp 11/20
Recall Number: D-0306-2020
Presence of Foreign substance: identified as a dead ant.
11-01-2019
11-13-2019
a) 4074 bottles b) 30,300 bottles
Recall Profile & Regulatory Data
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.
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.
Lupin Pharmaceuticals 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.
Product was distributed to major distributors/wholesalers throughout the United States.
03-04-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA
Batch or Lot Expiration Information
Lot# : a) F900153, Exp 11/20; b) F802327, F802328, F802329, Exp 11/20
Affected Packages Involved in this Recall
Recall Number: D-0305-2020
Presence of Foreign substance: identified as a dead ant.
11-01-2019
11-13-2019
30,516 bottles
Recall Profile & Regulatory Data
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.
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.
Lupin Pharmaceuticals 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.
Product was distributed to major distributors/wholesalers throughout the United States.
03-04-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-723-10
Batch or Lot Expiration Information
Lot# : F802345, F802346, F802347, Exp 11/20
