Class II
Terminated
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
This recall has been terminated (originally issued August 21, 2019).
- Company
- Macleods Pharma Usa Inc
- Recall Initiated
- July 17, 2019
- Posted
- August 21, 2019
- Recall Number
- D-1844-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 5448 bottles b) 972 bottles c) 158 bottles
- Firm Location
- Plainsboro, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications
Distribution
Nationwide
Lot / Code Info
a) BTP803A, exp 08/2020; b) BTP802A, exp 07/2020, BTP901A, exp 12/2020; c) BTP802B, exp 07/2020
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