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
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: a) 11957A, Exp 04/2017; b) 11956A, Exp 04/2017
Where it was sold
Nationwide
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-1371-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 14, 2015
- FDA report date
- Sep 2, 2015
- Quantity
- 9,696 bottles (100-count), 972 bottles (1000-count)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- KVK-Tech, Inc.
Original FDA data
Every field from FDA enforcement report D-1371-2015, exactly as published.
Show all FDA fields
- City
- Newtown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 71726
- Address
- 110 Terry Dr
- Code information
- Lot #: a) 11957A, Exp 04/2017; b) 11956A, Exp 04/2017
- Postal code
- 18940-3427
- Report date
- Sep 2, 2015
- Product type
- Drugs
- Recall number
- D-1371-2015
- Classification
- Class III
- Recalling firm
- KVK-Tech, Inc.
- Product quantity
- 9,696 bottles (100-count), 972 bottles (1000-count)
- Termination date
- Jan 13, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 14, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 25, 2015