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
Reported: October 23, 2019 Initiated: September 19, 2019 #D-0143-2020
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
Reason for Recall
Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
Details
- Recalling Firm
- Aurobindo Pharma USA Inc.
- Units Affected
- 11,129 100-count bottles
- Distribution
- Nationwide in the US
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Aurobindo Pharma USA Inc.. Units affected: 11,129 100-count bottles.
Why was this product recalled? ▼
Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 23, 2019. Severity: Moderate. Recall number: D-0143-2020.
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