Recall: D-0762-2022

Class III - Minor Violations

Class IIIClassification

2022-03-10Initiated

TerminatedStatus

Macleods Pharma Usa IncFirm

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

FAILED CONTENT UNIFORMITY SPECIFICATIONS

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.