D-1288-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 10, 2020
- Initiation Date
- May 22, 2020
- Termination Date
- October 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,443 cartons
Product Description
Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 0904-0430-06), Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152.
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
Nationwide within the United States
Code Information
Lot #: a) R00828D, Exp. date 08/2020, b) R00732D, Exp. date 05/2020; R00783D, Exp. date 06/2020; R00827D, Exp. date 08/2020