D-0142-2020 Class III Terminated
FDA drug recall D-0142-2020 was initiated by KVK-Tech, Inc. on October 4, 2019 and is designated Class III. Reason for recall: Presence of Foreign Substance; Fiber particles. The recall status is terminated (terminated April 20, 2020). Affected quantity: 384 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 23, 2019
- Initiation Date
- October 4, 2019
- Termination Date
- April 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 384 bottles
Product Description
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.
Reason for Recall
Presence of Foreign Substance; Fiber particles.
Distribution Pattern
Nationwide in the U.S.
Code Information
Batch # 15315A, Exp. 02/2021