February 2019 FDA Recall Lovastatin by Lupin Pharmaceuticals Inc.
D-0513-2019 - CGMP Deviations
This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on February 13, 2019 for the product Lovastatin. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0513-2019
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
02-13-2019
02-27-2019
44,640 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.
Nationwide in the USA and Puerto Rico.
10-06-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA.
Batch or Lot Expiration Information
Lot# : a) G702755, Exp March 2020; b) G702756, Exp March 2020
