Why it was recalled
Failed Dissolution Specifications
Product description
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
Lot numbers, UPCs & expiration codes
a) BTP803A, exp 08/2020; b) BTP802A, exp 07/2020, BTP901A, exp 12/2020; c) BTP802B, exp 07/2020
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1844-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 17, 2019
- FDA report date
- Aug 21, 2019
- Quantity
- a) 5448 bottles b) 972 bottles c) 158 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Macleods Pharma Usa Inc
Original FDA data
Every field from FDA enforcement report D-1844-2019, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83414
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230
- Code information
- a) BTP803A, exp 08/2020; b) BTP802A, exp 07/2020, BTP901A, exp 12/2020; c) BTP802B, exp 07/2020
- Postal code
- 08536-0009
- Report date
- Aug 21, 2019
- Product type
- Drugs
- Recall number
- D-1844-2019
- Classification
- Class II
- Recalling firm
- Macleods Pharma Usa Inc
- Product quantity
- a) 5448 bottles b) 972 bottles c) 158 bottles
- Termination date
- Feb 9, 2021
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 17, 2019
- Initial firm notification
- Letter
- Center classification date
- Aug 28, 2019