Antibiotic Tablets Recalled

West-Ward Columbus Inc. is recalling multiple lots of doxycycline hyclate tablets because samples failed to meet dissolution specifications during routine testing, according to the June 3, 2020, US Food and Drug Administration (FDA) Enforcement Report. 

Recalled are 100-mg doxycycline hyclate tablets manufactured by West-Ward Pharmaceuticals Corp. and packaged in:

• 50-count bottles (NDC 0143-2112-50) from lot 71846B (Exp. 6/21); and
• 500-count bottles (NDC 0143-2112-05) from lots 71726A (Exp. 6/20), 71846B (Exp. 6/21), and 71853A (Exp. 6/21).

Also recalled are 100-mg doxycycline hyclate tablets by PD-Rx Pharmaceuticals Inc. and packaged in:

• 6-count bottles (NDC 55289-866-06) from lot L18B72, (Exp. 12/31/20);
• 10-count bottles (NDC 55289-866-10) from lot I18B83 (Exp. 6/30/20);
• 14-count bottles (NDC 55289-866-14) from lots H18B11 (Exp. 6/30/20), I18A53 (Exp. 6/30/20), J18F97 (Exp. 10/31/20), K18A33 (Exp. 11/30/20), K18D17 (Exp. 11/30/20), L18A11 (Exp. 12/31/20), L18A29 (Exp. 12/31/20), and L18D81 (Exp. 12/31/20);
• 20-count bottles (NDC 55289-866-20) from lots H18F60 (Exp. 6/30/20), I18C26 (Exp. 6/30/20), I18D61 (Exp. 6/30/20), J18B80 (Exp. 10/31/20), K18C97 (Exp. 11/30/20), L18B30 (Exp. 12/31/20), L18D25 (Exp. 12/31/20), and L18E50 (Exp. 12/31/20);
• 28-count bottles (NDC 55289-866-28) from lots I18D07 (Exp. 6/30/20), J1E02 (Exp. 10/31/20), J18E62 (Exp. 10/31/20), K18E98 (Exp. 11/30/20), and L18C54 (Exp 12/31/20);
• 30-count bottles (NDC 55289-866-30) from lots H18E18 (Exp. 6/30/20), I18F94 (Exp. 9/30/20), J18E42 (Exp. 10/31/20), and L18B56 (Exp. 12/31/20);
• 60-count bottles (NDC 55289-866-60) from lots J18C84 (Exp. 10/31/20) and A19B70 (Exp. 1/31/21);
• 120-count bottles (NDC 55289-866-98) from lot K18E92 (Exp. 11/30/20);
• 210-count bottles (NDC 55289-866-71) from lots I18E80 (Exp. 6/30/20) and K18A19 (Exp. 11/30/20);
• 300-count bottles (NDC 55289-866-87) from lots F18E11 (Exp. 6/30/20), G18E66 (Exp. 6/30/20), H18E72 (Exp. 06/30/20), I18E75 (Exp. 9/30/20), I18E95 (Exp. 9/30/20), and I18F64 (Exp. 9/30/20); and
• 400-count bottles (NDC 55289-866-74) from lots A19D44 (Exp. 8/31/20), H18E76 (Exp. 6/30/20), I18F21 (Exp. 9/30/20), and L18B91 (Exp. 12/31/20). 

All doxycycline hyclate tablets included in the recalls were distributed in the United States. 

West-Ward initiated the voluntary recalls in mid-May. On May 26, 2020, the FDA designated the recalls Class II. Under Class II recalls, use of the product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

Doxycycline is a prescription antibiotic used to treat bacterial infections.

—Jolynn Tumolo