Drug product
Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-047-88.
D-0145-2026
Product summary
- Event
- Event 97874
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0145-2026
Official wording
Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Code information: Lot #: AD42469, Expiry: 2/28/2026; AD48707, Expiry:4/30/2026.
Distribution pattern: U.S Nationwide.
Derived failure modes
-
Potency or specification failure
out of specification