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Class II · Moderate risk Terminated Initiated Apr 10, 2013 (14 years ago)

Modified Myers Cocktail Injection

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.

Cause type: Sterility / contamination

A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.

What was recalled

Modified Myers Cocktail Injection, all strengths and all presentations including a) Mod Meyer's Cocktail 37 mL and b) Modified Myers Cocktail 37 mL, 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-396-2013 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other recalls by FVS Holdings, Inc. dba. Green Valley Drugs

All 2013 recalls
Class II · Moderate risk

Zinc Sulfate Injection

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.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-416-2013
Class II · Moderate risk

Triamcinolone Injection

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.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-415-2013
Class II · Moderate risk

Thiamine Hydrochloride Injection

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.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-414-2013
Class II · Moderate risk

Testosterone Cypionate Injection

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.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-413-2013

Other sterility / contamination recalls from 2013

All sterility / contamination recalls
Class II · Moderate risk

Vitamin B-12 injections

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

Terminated Sterility / contamination Zions RX Formulations Services LLC dba RX Formuations Serv. D-1219-2014
Class II · Moderate risk

Bupivacaine 3%

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

Terminated Sterility / contamination Zions RX Formulations Services LLC dba RX Formuations Serv. D-1218-2014