Recalls / Class II
Class IID-1236-2020
Product
Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01
- Brand name
- Phentermine
- Generic name
- Phentermine Hydrochloride
- Active ingredient
- Phentermine Hydrochloride
- Route
- Oral
- NDCs
- 13107-105, 13107-106
- FDA application
- ANDA204318
- Affected lot / code info
- Lot #: 105180004A, Exp. Date 03/2020
Why it was recalled
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurolife Pharma, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 2101 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-03-18
- FDA classified
- 2020-04-13
- Posted by FDA
- 2020-04-22
- Terminated
- 2024-03-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1236-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.