Class II · Moderate risk
Dextroamphetamine Saccharate
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Dextroamphetamine Sulfate Tablets USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10
Affected NDC
64720-0215-10
Compare with the code on your package — it is the most precise check available.
Drug: Dextroamphetamine
- Recalling firm
- Impax Laboratories, Inc.
- NDC code
- 64720-215-10
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0826-2016 · 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 Impax Laboratories, Inc.
All 2016 recalls
Class I · High risk
Lamotrigine Orally Disintegrating Tablets
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class II · Moderate risk
Dextroamphetamine Sulfate Tablets USP
Failed Impurities/Degradation Specifications
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