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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # a):12322A, 12323B, 12324A, Exp. Sep 2017; 12455A, Exp. Dec 2017; b) 12323A, Exp. Sep 2017; 12456A, Exp. Dec 2017
Where it was sold
Nationwide in the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1083-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 3, 2017
- FDA report date
- Aug 23, 2017
- Quantity
- 35,267 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- KVK-Tech, Inc.
Original FDA data
Every field from FDA enforcement report D-1083-2017, exactly as published.
Show all FDA fields
- City
- Newtown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 77878
- Address
- 110 Terry Dr
- Code information
- Lot # a):12322A, 12323B, 12324A, Exp. Sep 2017; 12455A, Exp. Dec 2017; b) 12323A, Exp. Sep 2017; 12456A, Exp. Dec 2017
- Postal code
- 18940-3427
- Report date
- Aug 23, 2017
- Product type
- Drugs
- Recall number
- D-1083-2017
- Classification
- Class III
- Recalling firm
- KVK-Tech, Inc.
- Product quantity
- 35,267 bottles
- Termination date
- Dec 4, 2018
- Reason for recall
- Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the United States
- Recall initiation date
- Aug 3, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 11, 2017