Drug recall D-1844-2019
Product
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, Manufactured : Macleods Pharma USA, Inc Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himchal Pradesh, INDIA
Reason for recall
Failed Dissolution Specifications
Lots and codes
a) BTP803A, exp 08/2020; b) BTP802A, exp 07/2020, BTP901A, exp 12/2020; c) BTP802B, exp 07/2020
Recall details
- Recalling firm
- Macleods Pharma Usa Inc, Plainsboro, NJ
- Quantity
- a) 5448 bottles b) 972 bottles c) 158 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 17, 2019
- Terminated
- February 9, 2021
Related products
- Tamsulosin Hydrochloride – drug information
- NDC 33342-159 Tamsulosin Hydrochloride · Tamsulosin Hydrochloride .4 mg/1 · Macleods Pharmaceuticals Limited