Reported Apr 13, 2022 · Terminated
Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ…
Macleods Pharma USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Macleods Pharma Usa Inc · 666 Plainsboro Rd Bldg 200 Ste 230 · Plainsboro, NJ · 08536-0009
Is this the product you have?
- Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle
- Manufactured forMacleods Pharma USA, Plainsboro, NJ 08536
- Manufactured byMacleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, INDIA, NDC 33342-107-07
- Lot codes and dates
Lot #: BRD2001AExp 5/2022
- Amount recalled
- 4872 bottles
Where it was sold
- Nationwide
Why it was recalled
FAILED CONTENT UNIFORMITY SPECIFICATIONS
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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