Aurobindo Recalls Amphetamine Mixed Salts Tablets for Out-of-Specification Weight
Aurobindo Pharma USA Inc. is recalling 11,129 bottles of 20mg Amphetamine Mixed Salts tablets because they failed weight and thickness specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a manufacturing deviation (weight/thickness) without reported adverse health consequences, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling 11,129 100-count bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 20mg. The affected product is identified by Batch 07319032A1 with an expiration date of 02/2021 and NDC 13107-073-01.
The recall was initiated because the tablets were found to be out of specification for weight and thickness. This is classified as an FDA Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The product was distributed nationwide in the US. Consumers and healthcare providers should check their inventory for the specific batch and expiration date listed above. If found, the product should be returned to the pharmacy or distributor for disposal or credit.
The recalled product
- Product
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
- Brand
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch 07319032A1
- Exp 02/2021
UPCs (5)
- 0313107070013
- 0313107068010
- 0313107071010
- 0313107074011
- 0313107073014
Distribution
Distributed nationwide across the United States.
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