ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date
ANI Pharmaceuticals is recalling 34,968 bottles of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of 18 months.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error regarding expiration dates.
Plain-English summary
ANI Pharmaceuticals, Inc. is recalling 34,968 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 30 mg, 100-count. The product is manufactured for Amerigen Pharmaceuticals, Inc. and is distributed nationwide in the USA.
The recall was initiated due to a labeling error where the product was dated with a 24-month expiration date instead of the correct 18-month expiration date. The affected lots include 19T17, 19T18, 19T19, 20D05, and 20D21, with expiration dates ranging from December 2021 to May 2022.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
- Brand
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
- Manufacturer
- ANI Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 34,968
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 (7)
- Lot: 19T17 Exp. Dec. 2021
- 19T18
- 19T19
- Exp. Jan. 2022
- 20D05 Exp. Apr. 2022
- 20D21
- Exp. May 2022
UPCs (6)
- 0343975282102
- 0343975281105
- 0343975278105
- 0343975280108
- 0343975277108
- 0343975279102
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by ANI Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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