HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 30ML PBF MDV 5MG/ML INJ, 5mg/mL, RX only, 30 mL Glass/ Multiple Dose vial.
Reported: May 24, 2017 Initiated: April 18, 2017 #D-0724-2017
Product Description
HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 30ML PBF MDV 5MG/ML INJ, 5mg/mL, RX only, 30 mL Glass/ Multiple Dose vial.
Reason for Recall
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Details
- Recalling Firm
- Key Pharmacy and Compounding Center
- Units Affected
- 8 vials total (6/10mL vials and 2/30 mL vials)
- Distribution
- Distributed nationwide in U.S.A., Australia and Canada.
- Location
- Federal Way, WA
Frequently Asked Questions
What product was recalled? ▼
HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 30ML PBF MDV 5MG/ML INJ, 5mg/mL, RX only, 30 mL Glass/ Multiple Dose vial.. Recalled by Key Pharmacy and Compounding Center. Units affected: 8 vials total (6/10mL vials and 2/30 mL vials).
Why was this product recalled? ▼
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 24, 2017. Severity: Moderate. Recall number: D-0724-2017.
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