PlainRecalls
FDA Drug Moderate Class II Terminated

Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01

Reported: April 22, 2020 Initiated: March 18, 2020 #D-1236-2020

Product Description

Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01

Reason for Recall

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Details

Recalling Firm
Aurobindo Pharma USA Inc.
Units Affected
2101 units
Distribution
Nationwide within the United States
Location
East Windsor, NJ

Frequently Asked Questions

What product was recalled?
Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01. Recalled by Aurobindo Pharma USA Inc.. Units affected: 2101 units.
Why was this product recalled?
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Which agency issued this recall?
This recall was issued by the FDA Drug on April 22, 2020. Severity: Moderate. Recall number: D-1236-2020.