Class II · Moderate risk
Dextroamphetamine Saccharate
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Teva Dextroamphetamine Saccharate
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
What was recalled
Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only, Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0972-02.
Affected NDC
0555-0972-02
Compare with the code on your package — it is the most precise check available.
Drug: Dextroamphetamine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate NDC 00555-0972 |
DEXTROAMPHETAMINE SACCHARATE 2.5 mg/1; AMPHETAMINE ASPARTATE MONOHYDRATE 2.5 mg/1; DEXTROAMPHETAMINE SULFATE 2.5 mg/1; AMPHETAMINE SULFATE 2.5 mg/1 | Tablet Oral |
Teva Pharmaceuticals USA, Inc. | Rx · CII |
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 0555-0972-02
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1094-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Dextroamphetamine recalls
See all
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Other recalls by Teva Pharmaceuticals USA
All 2014 recalls
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Class II · Moderate risk
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Class II · Moderate risk
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CGMP Deviations: use of an unapproved raw material
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