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
Reported: August 21, 2019 Initiated: July 17, 2019 #D-1844-2019
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
Reason for Recall
Failed Dissolution Specifications
Details
- Recalling Firm
- Macleods Pharma Usa Inc
- Units Affected
- a) 5448 bottles b) 972 bottles c) 158 bottles
- Distribution
- Nationwide
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Macleods Pharma Usa Inc. Units affected: a) 5448 bottles b) 972 bottles c) 158 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 21, 2019. Severity: Moderate. Recall number: D-1844-2019.
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