FDA Drug recall D-1844-2019
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 (N…
- FDA Drug
- Class II
- terminated
- Published 2019-08-21
On 2019-08-21 the FDA classified a Class II recall of 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 (N… by Macleods Pharma Usa, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1844-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-17 |
| Published | 2019-08-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Macleods Pharma Usa |
| Distribution | US |
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
Failed Dissolution Specifications
Identifiers
| ndc | 33342-159-07 |
|---|---|
| ndc | 33342-159-11 |
| ndc | 33342-159-44 |
| ndc | 33342-159-12 |
| ndc | 33342-159-15 |
| code_info | a) BTP803A, exp 08/2020; b) BTP802A, exp 07/2020, BTP901A, exp 12/2020; c) BTP802B, exp 07/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1844-2019%22
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