D-1033-2020 Class II Terminated
FDA drug recall D-1033-2020 was initiated by Sun Pharmaceutical Industries, Inc. on March 13, 2020 and is designated Class II. Reason for recall: CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions. The recall status is terminated (terminated February 9, 2021). Affected quantity: 172,320 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 25, 2020
- Initiation Date
- March 13, 2020
- Termination Date
- February 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 172,320 bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code 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