Class II · Moderate risk
Dextroamphetamine Saccharate
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Zenzedi (Dextroamphetamine Sulfate)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Labeling: Label Mix-up
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03
Affected NDC
24338-0856-03
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 |
|---|---|---|---|---|
| Zenzedi Dextroamphetamine Sulfate NDC 24338-0856 |
30 mg/1 | Tablet Oral |
Azurity Pharmaceuticals, Inc. | Rx · CII |
- Recalling firm
- Azurity Pharmaceuticals, Inc.
- NDC code
- 24338-856-03
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Jan 24, 2024 · FDA notice with lot numbers
- FDA recall number
- D-0323-2024 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. 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 Azurity Pharmaceuticals, Inc.
All 2024 recalls
Class III · Low risk
Eprontia (topiramate)
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Class II · Moderate risk
Testosterone Cypionate Injection
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class I · High risk
Firvanq (vancomycin hydrochloride for oral solution)
Product Mix-up: Incorrect diluent component included in the kit.
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