Reported Feb 5, 2020 · Terminated
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc.…
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?
- Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only
- Manufactured forMacleods Pharma USA, Inc. Plainsboro
- NJ Manufactured byMacleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10
- Lot codes and dates
Lot #: BMD8901BExp. Date 02/2021
- Amount recalled
- 10680 units
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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