Drug product
Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01
D-0573-2022
Product summary
- Event
- Event 89545
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2220 100-count bottles
- Official record key
drug-enforcement:D-0573-2022
Official wording
Reason: Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
Code information: lot# 25910009, Exp 01/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.