Amphetamine salt tablets recalled after bottles contained a lower strength tablet
Lannett mixed amphetamine salts tablets, 10 mg, lot 25283185A, are recalled because two bottles each contained one 5 mg tablet. 4,848 bottles are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a bottle containing a tablet of a different strength could lead to the wrong dose, and no injuries are reported.
Plain-English summary
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10 mg, in 100-tablet bottles and available on prescription only, distributed by Lannett Company, Inc. of Philadelphia, Pennsylvania, NDC 0527-0762-37, are being recalled. The affected product is lot 25283185A with an expiry of 02/28/2027, and the recall covers 4,848 bottles distributed in Ohio.
The recall was issued for the presence of a foreign tablet: two bottles labeled as the 10 mg product each contained one tablet of the 5 mg strength. The FDA classified the action as Class II.
Patients should check the lot number on their bottle against the recall and should ask their pharmacist before taking any tablet that does not match the expected appearance.
The recalled product
- Product
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
- Brand
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
- Manufacturer
- Lannett Company Inc.
- Category
- Drug — Central Nervous System
- Hazard
- foreign-tablet
- wrong-strength
- prescription-drug
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot#: 25283185A. Expiry: 02/28/2027
Distribution
Distributed in 1 state:
- OH
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