Recalls / Class III
Class IIID-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.
- Brand name
- Risedronate Sodium
- Generic name
- Risedronate Sodium
- Active ingredient
- Risedronate Sodium
- Route
- Oral
- NDCs
- 33342-107, 33342-108, 33342-109
- FDA application
- ANDA203533
- Affected lot / code info
- Lot #: BRD2001A, Exp 5/2022
Why it was recalled
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Recalling firm
- Firm
- Macleods Pharma Usa Inc
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230, Plainsboro, New Jersey 08536-0009
Distribution
- Quantity
- 4872 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2022-03-10
- FDA classified
- 2022-04-07
- Posted by FDA
- 2022-04-13
- Terminated
- 2023-06-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0762-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.