Class II · Moderate risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
National Drug Code
Is NDC 0555-0972-02 recalled?
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate · 100 TABLET in 1 BOTTLE (0555-0972-02)
Yes — this exact package was recalled
4 FDA recalls name the code 0555-0972-02 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
- Strength
- DEXTROAMPHETAMINE SACCHARATE 2.5 mg/1; AMPHETAMINE…
- Form
- Tablet · Oral
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Type
- Human Prescription Drug · DEA CII
- Product code
- 0555-0972
Recalls naming this package
Class II · Moderate risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: out of specification for unknown impurity
Class II · Moderate risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
Class II · Moderate risk
Teva Dextroamphetamine Saccharate
CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
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