Betamethasone Acetate and Betamethasone Sodium Injection, all strengths and all presentations including 6 mg/mL preservative free, 2 ml; 106 mg/mL 10 mL, and 6 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Reported: May 22, 2013 Initiated: April 10, 2013 #D-343-2013
Product Description
Betamethasone Acetate and Betamethasone Sodium Injection, all strengths and all presentations including 6 mg/mL preservative free, 2 ml; 106 mg/mL 10 mL, and 6 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Reason for Recall
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Details
- Recalling Firm
- FVS Holdings, Inc. dba. Green Valley Drugs
- Units Affected
- 4368 vials
- Distribution
- Nationwide
- Location
- Henderson, NV
Frequently Asked Questions
What product was recalled? ▼
Betamethasone Acetate and Betamethasone Sodium Injection, all strengths and all presentations including 6 mg/mL preservative free, 2 ml; 106 mg/mL 10 mL, and 6 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.. Recalled by FVS Holdings, Inc. dba. Green Valley Drugs. Units affected: 4368 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 22, 2013. Severity: Moderate. Recall number: D-343-2013.
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