Recalls / Class II
Class IID-1033-2020
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.
- Brand name
- Doxycycline
- Generic name
- Doxycycline
- Active ingredient
- Doxycycline
- Route
- Oral
- NDCs
- 63304-614, 63304-615, 63304-616
- FDA application
- ANDA065053
- Affected lot / code info
- 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
Why it was recalled
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 172,320 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2020-03-13
- FDA classified
- 2020-03-18
- Posted by FDA
- 2020-03-25
- Terminated
- 2021-02-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1033-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.