Class II · Moderate risk Ongoing
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by…
Reason Lack of Assurance of Sterility
Bupivacaine and Dexamethasone Injection, all strengths and all presentations including…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was 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.
What was recalled
Bupivacaine and Dexamethasone Injection, all strengths and all presentations including Bupiv_Dexameth-0.25-10.5; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
- Recalling firm
- FVS Holdings, Inc. dba. Green Valley Drugs
- Origin
- NV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-351-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Bupivacaine recalls
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Class II · Moderate risk Ongoing
BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx…
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk Ongoing
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL)…
Reason Lack of Assurance of Sterility
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