NDC 16590-901
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Suflate 4 ingredients tablet
On the label: Stat Rx USA. It's repackaged: Stat Rx USA rebottles it from Teva Pharmaceuticals USA, Inc.'s NDC 0555-0974.
Where the pills inside were made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Teva Pharmaceuticals USA, Inc. names for other drugs.
Recalls
- Aug 29, 2022 · Class II · Teva Pharmaceuticals USA Inc
Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
Lots: Lot #: 100023340, Exp 10/2024 - May 22, 2020 · Class II · Teva Pharmaceuticals USA
Some bottles may contain mixed strengths of the product.
Lots: Lot #: 42614718, Exp. date 02/2021 - May 22, 2020 · Class II · Teva Pharmaceuticals USA
Some bottles may contain mixed strengths of the product.
Lots: Lot #: 42617008, Exp. date 10/2021 - May 22, 2020 · Class II · Teva Pharmaceuticals USA
Some bottles may contain mixed strengths of the product.
Lots: Lot #: 42617891, exp. date 01/2022 - Nov 12, 2015 · Class II · Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Lots: Lot #: 34015516A, Exp 05/16 - Jun 24, 2015 · Class II · Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: out of specification for unknown impurity
Lots: Lot #: 34015862A, Exp. Date 6/2016 Lot #: 34016376A, Exp. Date 7/2016 - Oct 8, 2014 · Class II · Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
Lots: Lot #: 34016373A, Expiry: 7/2016; Lot #: 34016377A, Expiry: 7/2016. - Jan 24, 2014 · Class II · Teva Pharmaceuticals USA
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.
Lots: Lot # 34017575A, Exp. 10/16.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Amphetamine and Dextroamphetamine: every company that makes it
- Form
- tablet
- Strength
- 4 ingredients
- Approval
- ANDA ANDA040422
- On the market since
- Dec 18, 2009
- Package NDCs
16590-901-3016590-901-6016590-901-90- Official label
- DailyMed (National Library of Medicine), updated Jun 25, 2010
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