Drug 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.
D-0142-2020
Product summary
- Firm
- KVK-Tech, Inc.
- Event
- Event 83851
- Status
- Terminated
- Classification
- Class III
- Quantity
- 384 bottles
- Official record key
drug-enforcement:D-0142-2020
Official wording
Reason: Presence of Foreign Substance; Fiber particles.
Code information: Batch # 15315A, Exp. 02/2021
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance