Class II · Moderate risk
Vancomycin Injection
CGMP Deviations
Firvanq (vancomycin hydrochloride for oral solution)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Product Mix-up: Incorrect diluent component included in the kit.
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
Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydrochloride USP, powder for oral solution and 1 bottle containing 145 mL Grape Flavored Diluent for reconstitution per carton, Rx only, Manufactured for: Azurity pharmaceuticals, Wilmington, MA 01887, NDC 65628-206-05.
Affected NDC
65628-0206-05
Compare with the code on your package — it is the most precise check available.
Drug: Vancomycin
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 |
|---|---|---|---|---|
| Firvanq vancomycin hydrochloride NDC 65628-0206 |
Kit | Azurity Pharmaceuticals, Inc | Rx |
- Recalling firm
- Azurity Pharmaceuticals, Inc.
- NDC code
- 65628-206-05
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0003-2022 · 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 Vancomycin recalls
See all
Class II · Moderate risk
Vancomycin Injection
CGMP Deviations
Class II · Moderate risk
Vancomycin HCL
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk
Vancomycin HCI
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk
Vancomycin HCI
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Other recalls by Azurity Pharmaceuticals, Inc.
All 2021 recalls
Class I · High risk
Zenzedi (Dextroamphetamine Sulfate)
Labeling: Label Mix-up
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.
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