KVK-Tech Recalls Methylphenidate Hydrochloride Oral Solution Due to Foreign Particles
KVK-Tech is recalling 384 bottles of Methylphenidate Hydrochloride Oral Solution because of the presence of fiber particles.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
KVK-Tech, Inc. is recalling 384 bottles of Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only. The product is identified by Batch # 15315A and has an expiration date of 02/2021. The recall was initiated due to the presence of foreign substances, specifically fiber particles, in the medication.
The affected product was distributed nationwide in the U.S. The recall is classified as Class III by the U.S. Food and Drug Administration, indicating that the violation is not likely to cause adverse health consequences.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The recalling firm is KVK-Tech, Inc., located in Newtown, PA.
The recalled product
- 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.
- Manufacturer
- KVK-Tech, Inc.
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 384
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch # 15315A
- Exp. 02/2021
Distribution
Distributed nationwide across the United States.
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