FDAMay 13, 2020drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

west ward columbuswestwest ward

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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