Why it was recalled
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Product description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 20 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-280-10
Lot numbers, UPCs & expiration codes
Lot: 19T15 Exp. Dec. 2021, 20D02, 20D03 Exp. Mar. 2022
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0046-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 9, 2020
- FDA report date
- Oct 28, 2020
- Quantity
- 24972 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ANI Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0046-2021, exactly as published.
Show all FDA fields
- City
- Baudette
- State
- MN
- Status
- Terminated
- Country
- United States
- Event ID
- 86584
- Address
- 455 Idc Rd Sw
- Code information
- Lot: 19T15 Exp. Dec. 2021, 20D02, 20D03 Exp. Mar. 2022
- Postal code
- 56623-2467
- Report date
- Oct 28, 2020
- Product type
- Drugs
- Recall number
- D-0046-2021
- Classification
- Class III
- Recalling firm
- ANI Pharmaceuticals, Inc.
- Product quantity
- 24972 bottles
- Termination date
- Jan 19, 2022
- Reason for recall
- Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 20 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-280-10
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Oct 9, 2020
- Initial firm notification
- Letter
- Center classification date
- Oct 21, 2020