Class II · Moderate risk
Vancomycin Injection
CGMP Deviations
Vancomycin Hydrochloride for Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01
Affected NDC
0409-6510-01
Compare with the code on your package — it is the most precise check available.
Drug: Vancomycin
- Recalling firm
- Hospira Inc., A Pfizer Company
- NDC code
- 0409-6510-01
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0638-2017 · 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 Hospira Inc., A Pfizer Company
All 2017 recalls
Class II · Moderate risk
Labetalol Hydrochloride Injection
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Class III · Low risk
Argatroban Injection
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Class II · Moderate risk
Neut Sodium Bicarbonate 4%
Lack of Sterility Assurance
Class II · Moderate risk
Succinylcholine Chloride Injection
Lack of Sterility Assurance
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