Reported Oct 28, 2020 · Terminated
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate…
ANI Pharmaceuticals, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ANI Pharmaceuticals, Inc. · 455 Idc Rd Sw · Baudette, MN · 56623-2467
Is this the product you have?
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 15 mg, 100-count bottle, Rx Only, Mfd
- forAmerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-279-10
- Lot codes and dates
- Lot
19T14 Exp. Dec. 202120D06 Exp. Apr. 2022
- Lot
- Amount recalled
- 13248 bottles
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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