FDA recall D-1330-2022

Product

Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-785-06.

Reason for recall

Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2022-07-19

Report date

2022-08-17

Termination date

2023-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1330-2022