Class II · Moderate risk
HCL 2mg/Ml
Lack of Assurance of Sterility
NA Ascorbate 500 mg/mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the 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
NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183
- Recalling firm
- Medaus, Inc.
- Origin
- AL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1054-2013 · 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 recalls by Medaus, Inc.
All 2013 recalls
Class II · Moderate risk
Zinc So4 1mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Arginine 100mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Zinc So4 10mg/Ml
Lack of Assurance of Sterility
Other sterility / contamination recalls from 2013
All sterility / contamination recalls
Class II · Moderate risk
All Unexpired Sterile Drug Products
Lack of Assurance of Sterility
Class I · High risk
MINERAL IV Injection
Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis
Class II · Moderate risk
Vitamin B-12 injections
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Class II · Moderate risk
Bupivacaine 3%
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
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