Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.

FDA recall notice · announced June 3, 2020 · West-ward Columbus

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.

Reason for recall

Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.

Notes

Distribution: USA Nationwide
Lot/code information: Lot #: a) 71846B, Exp 6/2021; b) 71726A, Exp 6/2020; 71846B, 71853A, Exp 6/2021
Quantity: 68,376 bottles
Status: Terminated
Products in this recall event:
- Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 077 (D-1274-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.