Recalls / Class III
Class IIID-1371-2015
Product
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA
- Affected lot / code info
- Lot #: a) 11957A, Exp 04/2017; b) 11956A, Exp 04/2017
Why it was recalled
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Recalling firm
- Firm
- KVK-Tech, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 110 Terry Dr, N/A, Newtown, Pennsylvania 18940-3427
Distribution
- Quantity
- 9,696 bottles (100-count), 972 bottles (1000-count)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-07-14
- FDA classified
- 2015-08-25
- Posted by FDA
- 2015-09-02
- Terminated
- 2017-01-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1371-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.