Recalls / Class III
Class IIID-1083-2017
Product
Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940
- Brand name
- Phentermine Hydrochloride
- Generic name
- Phentermine Hydrochloride
- Active ingredient
- Phentermine Hydrochloride
- Route
- Oral
- NDCs
- 10702-026, 10702-027, 10702-028
- FDA application
- ANDA040886
- Affected lot / code info
- Lot # a):12322A, 12323B, 12324A, Exp. Sep 2017; 12455A, Exp. Dec 2017; b) 12323A, Exp. Sep 2017; 12456A, Exp. Dec 2017
Why it was recalled
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
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
- 35,267 bottles
- Distribution pattern
- Nationwide in the United States
Timeline
- Recall initiated
- 2017-08-03
- FDA classified
- 2017-08-11
- Posted by FDA
- 2017-08-23
- Terminated
- 2018-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1083-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.