FDA recall D-1288-2020

Product

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

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2020-05-22

Report date

2020-06-10

Termination date

2022-10-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1288-2020