Class II · Moderate risk
Dextroamphetamine Saccharate
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Dextroamphetamine Sulfate Extended-Release Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA NDC 45963-304-09
Affected NDC
45963-0304-09
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 sulfate NDC 45963-0304 |
10 mg/1 | Capsule, Extended Release Oral |
Actavis Pharma, Inc. | Rx · CII |
- Recalling firm
- Actavis Inc
- NDC code
- 45963-304-09
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1448-2016 · 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 Actavis Inc
All 2016 recalls
Class III · Low risk
Levofloxacin Ophthalmic Solution
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Class II · Moderate risk
Glipizide extended-release tablets
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Class III · Low risk
Albuterol Sulfate Inhalation Solution
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Class III · Low risk
Hydrocortisone and acetic acid otic solution
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
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