FDA-Drug2025-07-23Class II
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
SUN PHARMACEUTICAL INDUSTRIES INC
Hazard
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).
Sold states
Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
Affected count
5,448 bottles
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0516-2025Don't want to check this manually?
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