Recalls / Class II
Class IID-0143-2020
Product
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
- Brand name
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate
- Generic name
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate
- Active ingredients
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate
- Route
- Oral
- NDCs
- 13107-068, 13107-069, 13107-070, 13107-071, 13107-072, 13107-073, 13107-074
- FDA application
- ANDA202424
- Affected lot / code info
- Batch 07319032A1, Exp 02/2021
Why it was recalled
Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurolife Pharma, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 11,129 100-count bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2019-09-19
- FDA classified
- 2019-10-15
- Posted by FDA
- 2019-10-23
- Terminated
- 2023-04-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0143-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.