Why it was recalled
Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
Product description
Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Salts of a single Entity Amphetamine Product), 20mg, 100-count bottle, RX Only, Distributed by: Aurobindo Pharma USA Inc., Dayton, NJ 08810, NDC 13107-073-01
Lot numbers, UPCs & expiration codes
Batch 07319032A1, Exp 02/2021
Where it was sold
Nationwide in the US
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-0143-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 19, 2019
- FDA report date
- Oct 23, 2019
- Quantity
- 11,129 100-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc.
Original FDA data
Every field from FDA enforcement report D-0143-2020, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83848
- Address
- 279 Princeton Hightstown Rd
- Code information
- Batch 07319032A1, Exp 02/2021
- Postal code
- 08520-1401
- Report date
- Oct 23, 2019
- Product type
- Drugs
- Recall number
- D-0143-2020
- Classification
- Class II
- Recalling firm
- Aurobindo Pharma USA Inc.
- Product quantity
- 11,129 100-count bottles
- Termination date
- Apr 4, 2023
- Reason for recall
- Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Salts of a single Entity Amphetamine Product), 20mg, 100-count bottle, RX Only, Distributed by: Aurobindo Pharma USA Inc., Dayton, NJ 08810, NDC 13107-073-01
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Sep 19, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 15, 2019