Multi-event January 2024 FDA Recall Rifampin by Lupin Pharmaceuticals Inc.
This Multi-event Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on January 5, 2024 for the product Rifampin. The FDA reported the reason for recall as subpotent drug and failed impurities/degradation specifications. The product was distributed in Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites. and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0283-2024
Subpotent Drug and Failed Impurities/Degradation Specifications
01-05-2024
02-07-2024
15,576 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.
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 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
08-27-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06
Batch or Lot Expiration Information
Lot# A200816 exp 1/2024 A201248 exp 3/2024
Affected Packages Involved in this Recall
Recall Number: D-0284-2024
Subpotent Drug and Failed Impurities/Degradation Specifications
01-05-2024
02-07-2024
165,60 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.
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 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
08-27-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06
Batch or Lot Expiration Information
Lot# A200817 exp 1/2024
