Drug recall D-1033-2020

Class II Terminated reported Mar 25, 2020

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.

Reason for recall

CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.

Lots and codes

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

Recall details

Recalling firm
Sun Pharmaceutical Industries, Inc., Cranbury, NJ
Quantity
172,320 bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
March 13, 2020
Terminated
February 9, 2021

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