Recalls / Class II
Class IID-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
- Brand name
- Tamsulosin Hydrochloride
- Generic name
- Tamsulosin Hydrochloride
- Active ingredient
- Tamsulosin Hydrochloride
- Route
- Oral
- NDC
- 33342-159
- FDA application
- ANDA204645
- Affected lot / code info
- a) BTP803A, exp 08/2020; b) BTP802A, exp 07/2020, BTP901A, exp 12/2020; c) BTP802B, exp 07/2020
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Macleods Pharma Usa Inc
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230, N/A, Plainsboro, New Jersey 08536-0009
Distribution
- Quantity
- a) 5448 bottles b) 972 bottles c) 158 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-07-17
- FDA classified
- 2019-08-28
- Posted by FDA
- 2019-08-21
- Terminated
- 2021-02-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1844-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.