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.
Reported: April 13, 2022 Initiated: March 10, 2022 #D-0762-2022
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.
Reason for Recall
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Details
- Recalling Firm
- Macleods Pharma Usa Inc
- Units Affected
- 4872 bottles
- Distribution
- USA Nationwide
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Macleods Pharma Usa Inc. Units affected: 4872 bottles.
Why was this product recalled? ▼
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 13, 2022. Severity: Low. Recall number: D-0762-2022.
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