Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
Reported: December 11, 2024 Initiated: October 25, 2024 #D-0112-2025
Product Description
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
Reason for Recall
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Details
- Recalling Firm
- Lannett Company Inc.
- Units Affected
- 1608 bottles
- Distribution
- Nationwide in the USA
- Location
- Seymour, IN
Frequently Asked Questions
What product was recalled? ▼
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37. Recalled by Lannett Company Inc.. Units affected: 1608 bottles.
Why was this product recalled? ▼
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 11, 2024. Severity: Moderate. Recall number: D-0112-2025.
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