Recalls / Class III
Class IIID-1057-2016
Product
Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03
- Affected lot / code info
- Lot #: 12825 A, 12937A, Exp 8/18
Why it was recalled
Discoloration: presence of scuffing marks on tablets.
Recalling firm
- Firm
- KVK-Tech, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 110 Terry Dr, Newtown, Pennsylvania 18940-3427
Distribution
- Quantity
- 9360 bottles of lot # 12825A and 7284 bottles of lot # 12937A
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-05-05
- FDA classified
- 2016-06-28
- Posted by FDA
- 2016-07-06
- Terminated
- 2017-01-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1057-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.