Class II
Terminated
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.
- Company
- West-Ward Columbus, Inc.
- Recall Initiated
- May 13, 2020
- Posted
- June 3, 2020
- Recall Number
- D-1274-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 68,376 bottles
- Firm Location
- Columbus, OH, United States
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.
Distribution
USA Nationwide
Lot / Code Info
Lot #: a) 71846B, Exp 6/2021; b) 71726A, Exp 6/2020; 71846B, 71853A, Exp 6/2021
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