Multi-event February 2016 FDA Recall Amlodipine Besylate by Lupin Limited
This Multi-event Class III drug recall was voluntarily initiated by Lupin Limited on February 19, 2016 for the product Amlodipine Besylate. The FDA reported the reason for recall as cgmp deviations. The product was distributed in US No recalled product was distributed to any foreign consignees by Lupin. and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1493-2016
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
02-19-2016
09-14-2016
11,812 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 Limited
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US No recalled product was distributed to any foreign consignees by Lupin.
04-03-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03
Batch or Lot Expiration Information
Lot# : G304677, G304540, G304536, G304537, G304535, G304541, G304545, G304533, G304532, G304539, G304538, G304534, Exp. 4/2016
Affected Packages Involved in this Recall
Recall Number: D-1492-2016
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
02-19-2016
09-14-2016
43,536 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 Limited
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US No recalled product was distributed to any foreign consignees by Lupin.
04-03-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09
Batch or Lot Expiration Information
Lot# : G304799, Exp. 4/2016
