FDA recall D-0762-2022

Product

Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, INDIA, NDC 33342-107-07.

Reason for recall

FAILED CONTENT UNIFORMITY SPECIFICATIONS

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2022-03-10

Report date

2022-04-13

Termination date

2023-06-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0762-2022