Why it was recalled
Discoloration: presence of scuffing marks on tablets.
Product description
Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03
Lot numbers, UPCs & expiration codes
Lot #: 12825 A, 12937A, Exp 8/18
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-1057-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 5, 2016
- FDA report date
- Jul 6, 2016
- Quantity
- 9360 bottles of lot # 12825A and 7284 bottles of lot # 12937A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- KVK-Tech, Inc.
Original FDA data
Every field from FDA enforcement report D-1057-2016, exactly as published.
Show all FDA fields
- City
- Newtown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 74086
- Address
- 110 Terry Dr
- Code information
- Lot #: 12825 A, 12937A, Exp 8/18
- Postal code
- 18940-3427
- Report date
- Jul 6, 2016
- Product type
- Drugs
- Recall number
- D-1057-2016
- Classification
- Class III
- Recalling firm
- KVK-Tech, Inc.
- Product quantity
- 9360 bottles of lot # 12825A and 7284 bottles of lot # 12937A
- Termination date
- Jan 13, 2017
- Reason for recall
- Discoloration: presence of scuffing marks on tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03
- Distribution pattern
- Nationwide
- Recall initiation date
- May 5, 2016
- Initial firm notification
- Letter
- Center classification date
- Jun 28, 2016