FDA recall D-1274-2020

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.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2020-05-13

Report date

2020-06-03

Termination date

2023-03-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1274-2020