Drug recall D-1274-2020

Class II Terminated reported Jun 3, 2020

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.

Lots and codes

Lot #: a) 71846B, Exp 6/2021; b) 71726A, Exp 6/2020; 71846B, 71853A, Exp 6/2021

Recall details

Recalling firm
West-Ward Columbus Inc, Columbus, OH
Quantity
68,376 bottles
Distribution
USA Nationwide
Type
Voluntary: Firm initiated
Recall initiated
May 13, 2020
Terminated
March 25, 2023

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