Multi-event March 2020 FDA Recall Doxycycline by Sun Pharmaceutical Industries, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries, Inc. on March 13, 2020 for the product Doxycycline. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1032-2020
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
03-13-2020
03-25-2020
624 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.
Sun Pharmaceutical Industries, 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
02-09-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-615-01.
Batch or Lot Expiration Information
Lot# : AA39490, Exp 03/2021
Affected Packages Involved in this Recall
Recall Number: D-1033-2020
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
03-13-2020
03-25-2020
172,320 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.
Sun Pharmaceutical Industries, 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
02-09-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-616-50.
Batch or Lot Expiration Information
Lot# : 3983720, Exp 10/2020; 3990461, 3990464, 3990465, 3990466, 3990470, Exp 11/2020; AA42499, AA42510, AA44468, AA44470, Exp 04/2021; AA55073, AA55074, AA55075, Exp 05/2021; AA61486, Exp 06/2021
