Drug product
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88
D-0516-2025
Product summary
- Event
- Event 97092
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,448 bottles
- Official record key
drug-enforcement:D-0516-2025
Official wording
Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
Code information: Lot # AD42648, Exp 02/28/2026
Distribution pattern: Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
Derived failure modes
-
Potency or specification failure
out of specification