Class II · Moderate risk
Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine…
Lack of assurance of sterility.
Vaniqa (eflornithine hydrochloride)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt. 1.59 oz (45 g) Rx only NDC 0023-4857-45 Manufactured for Allegan, Inc. Irvine, CA 92612
Affected NDC
0023-4857-45
Compare with the code on your package — it is the most precise check available.
Drug: Ornithine
- Recalling firm
- Cardinal Health Inc.
- NDC code
- 0023-4857-45
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0414-2021 · 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 Ornithine recalls
See all
Class II · Moderate risk
GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml)
Lack of Assurance of Sterility
Class II · Moderate risk
Goal-Glutamine 75mg/Ornithine 75mg/Arginine 150mg/Lysine…
Lack of assurance of sterility
Class II · Moderate risk
Amino Blend Injection
Lack of sterility assurance.
Class II · Moderate risk
Ultra Amino Blend
Lack of Assurance of Sterility
Other recalls by Cardinal Health Inc.
All 2021 recalls
Class II · Moderate risk
Enoxaparin Sodium Injection
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Class II · Moderate risk
Recombinate
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
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