March 27, 2020
Sun Pharmaceutical Industries Inc. is recalling more than 170,000 bottles of doxycycline capsules. According to the March 25, 2020, US Food and Drug Administration (FDA) Enforcement Report, the capsules were manufactured under conditions that failed to meet Current Good Manufacturing Practices.
The recall affects the following doxycycline products, which were manufactured by Ohm Laboratories Inc. and distributed by Sun Pharmaceutical Industries throughout the United States:
- doxycycline capsules, 75 mg, 100-count bottles (NDC 63304-615-01) from lot AA39490 (Exp. 3/21); and
- doxycycline capsules, 100 mg, 50-count bottles (NDC 63304-616-50) from lots 3983720 (Exp. 10/20); 3990461, 3990464, 3990465, 3990466, and 3990470 (Exp. 11/20); AA42499, AA42510, AA44468, and AA44470 (Exp. 4/21); AA55073, AA55074, and AA55075 (Exp. 5/21); and AA61486 (Exp. 6/21).
Sun Pharmaceutical Industries voluntarily initiated the recall March 13, 2020. The FDA designated the recall Class II on March 18, 2020. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used, according to the FDA. A remote possibility of serious harm also exists.
Doxycycline is a prescription antibiotic used to treat a variety of bacterial infections, such as acne, urinary tract infections, and respiratory infections.