Why it was recalled
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: BRD2001A, Exp 5/2022
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0762-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 10, 2022
- FDA report date
- Apr 13, 2022
- Quantity
- 4872 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Macleods Pharma Usa Inc
Original FDA data
Every field from FDA enforcement report D-0762-2022, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89766
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230
- Code information
- Lot #: BRD2001A, Exp 5/2022
- Postal code
- 08536-0009
- Report date
- Apr 13, 2022
- Product type
- Drugs
- Recall number
- D-0762-2022
- Classification
- Class III
- Recalling firm
- Macleods Pharma Usa Inc
- Product quantity
- 4872 bottles
- Termination date
- Jun 29, 2023
- Reason for recall
- FAILED CONTENT UNIFORMITY SPECIFICATIONS
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Mar 10, 2022
- Initial firm notification
- Letter
- Center classification date
- Apr 7, 2022