Recall: D-1274-2020

Class II - Potentially Harmful

Class IIClassification

2020-05-13Initiated

TerminatedStatus

West-Ward Columbus IncFirm

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

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

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.