5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Reported: May 24, 2017 Initiated: April 18, 2017 #D-0710-2017
Product Description
5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single 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
- 63 vials total (29/1 mL vials; 30/2 mL vials; 3/5 mL vials, and 1/10 mL vial)
- Distribution
- Distributed nationwide in U.S.A., Australia and Canada.
- Location
- Federal Way, WA
Frequently Asked Questions
What product was recalled? ▼
5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy. Recalled by Key Pharmacy and Compounding Center. Units affected: 63 vials total (29/1 mL vials; 30/2 mL vials; 3/5 mL vials, and 1/10 mL vial).
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-0710-2017.
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