HYDROXO-B12 5ML PBF MDV 1MG/ML INJ, Injection, 1mg/ml, Rx only, packaged in 5 mL Glass/ Multiple Dose and 30 mL Glass/ Multiple Dose vials,Prepared by Key Compounding Pharmacy
Reported: May 24, 2017 Initiated: April 18, 2017 #D-0725-2017
Product Description
HYDROXO-B12 5ML PBF MDV 1MG/ML INJ, Injection, 1mg/ml, Rx only, packaged in 5 mL Glass/ Multiple Dose and 30 mL Glass/ Multiple Dose vials,Prepared by Key Compounding Pharmacy
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
- 7 vials total (1/5mL vial and 6/30 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 5ML PBF MDV 1MG/ML INJ, Injection, 1mg/ml, Rx only, packaged in 5 mL Glass/ Multiple Dose and 30 mL Glass/ Multiple Dose vials,Prepared by Key Compounding Pharmacy. Recalled by Key Pharmacy and Compounding Center. Units affected: 7 vials total (1/5mL vial and 6/30 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-0725-2017.
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