Recalls / Class III
Class IIID-0142-2020
Product
Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown, PA 18940, NDC 10702-0163-50.
- Affected lot / code info
- Batch # 15315A, Exp. 02/2021
Why it was recalled
Presence of Foreign Substance; Fiber particles.
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
- 384 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2019-10-04
- FDA classified
- 2019-10-15
- Posted by FDA
- 2019-10-23
- Terminated
- 2020-04-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0142-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.