Class II · Moderate risk
Hylenex recombinant
cGMP Deviations: Temperature excursion
Hyaluron (hyaluronidase)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
Drug: Hyaluronidase
- Recalling firm
- Leiter's Pharmacy
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1039-2013 · 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 Hyaluronidase recalls
See all
Class II · Moderate risk
Lidocaine HCL / Bupivacaine HCL
Lack of Assurance of Sterility
Class II · Moderate risk
LIDOcaine 2%
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Hyaluronidase
Lack of Assurance of Sterility
Other recalls by Leiter's Pharmacy
All 2013 recalls
Class II · Moderate risk
Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of these products cannot be assured.
Class II · Moderate risk
Bevacizumab
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of the products cannot be assured.
Class II · Moderate risk
Dextrose 50% Preservative Free SDV Injection Solution
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured.
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