Drug 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
D-1844-2019
Product summary
- Event
- Event 83414
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 5448 bottles b) 972 bottles c) 158 bottles
- Official record key
drug-enforcement:D-1844-2019
Official wording
Reason: Failed Dissolution Specifications
Code information: a) BTP803A, exp 08/2020; b) BTP802A, exp 07/2020, BTP901A, exp 12/2020; c) BTP802B, exp 07/2020
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications