D-1274-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 3, 2020
- Initiation Date
- May 13, 2020
- Termination Date
- March 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68,376 bottles
Product Description
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.
Distribution Pattern
USA Nationwide
Code Information
Lot #: a) 71846B, Exp 6/2021; b) 71726A, Exp 6/2020; 71846B, 71853A, Exp 6/2021