ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date
ANI Pharmaceuticals is recalling 408 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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding the expiration date.
Plain-English summary
ANI Pharmaceuticals, Inc. is recalling 408 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg. The product is manufactured for Amerigen Pharmaceuticals, Inc. and is available in 100-count bottles. The specific lot affected is 19S07, with an expiration date of September 2021.
The recall was initiated due to a labeling error. The affected product bottles were dated with a 24-month expiration date instead of the correct 18-month expiration date. The product was distributed nationwide in the USA.
Consumers who have this specific product should stop using it and contact their healthcare provider or pharmacist for further instructions. The recall is classified as Class III by the FDA, indicating that 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 Stimulant
- Hazard
- Affected units
- 408
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: 19S07 Exp. Sept. 2021
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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