Reported Aug 21, 2019 · Terminated
Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 33342-159-15)…
Macleods Pharma USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 33342-159-15) and c) 1000 count (NDC 33342-159-44) bottles
- ManufacturedMacleods Pharma USA, Inc Plainsboro
- NJ Manufactured byMacleods Pharmaceuticals Ltd Baddi, Himchal Pradesh, INDIA
- Lot codes and dates
a) BTP803Aexp 08/2020b) BTP802Aexp 07/2020BTP901Aexp 12/2020c) BTP802Bexp 07/2020
- Amount recalled
- a) 5448 bottles b) 972 bottles c) 158 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications
This product could cause temporary or reversible health problems — stop using it.
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