ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date
ANI Pharmaceuticals is recalling specific lots 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 indicates the product is not likely to cause adverse health consequences. The issue is a documentation/labeling error regarding the expiration date, which fits the criteria for a Low severity score.
Plain-English summary
ANI Pharmaceuticals, Inc. is recalling 13,536 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 10 mg. The affected product is manufactured for Amerigen Pharmaceuticals, Inc. and is identified by NDC 43975-278-10. The recall involves Lot 19S10 (Exp. Sept. 2021) and Lot 19S11 (Exp. Oct. 2021).
The recall was initiated due to a labeling error. The product was dated with a 24-month expiration date instead of the correct 18-month expiration date. This discrepancy means the expiration date printed on the packaging does not reflect the actual shelf life of the medication.
The affected bottles were distributed nationwide in the USA. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the description, it should be returned to the pharmacy or point of purchase for a refund or replacement, as directed by the recalling firm.
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
- 13,536
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 (2)
- Lot: 19S10 Exp. Sept. 2021
- 19S11 Exp. Oct. 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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