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.
Recall initiated: 20200513
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated