Drug Recall
Terminated
Historical recordClass II
Cyanocobalamin Injection, all strengths and all presentations including a) Cyanocobalamin 1000mcg, b) Cyanocobalamin 1000 mcg/mL in 1 mL, 10 mL, and 30 mL and 1 mL Preservative Free, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
by FVS Holdings, Inc. dba. Green Valley Drugs
- Reason
- 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.
- Recall initiated
- April 10, 2013
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Vitamin D3 Injection, all strengths and all presentations including a) Cholecalciferol D3 50,000iu 30 mL, b) Calcitriol D3 10,000iu, and c) Calcitriol D3 50,000iu, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
by FVS Holdings, Inc. dba. Green Valley Drugs
- Reason
- 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.
- Recall initiated
- April 10, 2013
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Buprenorphine Injection, all strengths and all presentations including Buprenorphine-0.3 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
by FVS Holdings, Inc. dba. Green Valley Drugs
- Reason
- 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.
- Recall initiated
- April 10, 2013
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Bupivacaine Injection, all strengths and all presentations including a) Bupivacaine Parabens Free 0.5% 50 mL, and b) Bupivacaine PF 0.5% 30 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
by FVS Holdings, Inc. dba. Green Valley Drugs
- Reason
- 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.
- Recall initiated
- April 10, 2013
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
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.
by FVS Holdings, Inc. dba. Green Valley Drugs
- Reason
- 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.
- Recall initiated
- April 10, 2013
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Biotin Injection, all strengths and all presentations including Biotin-15-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
by FVS Holdings, Inc. dba. Green Valley Drugs
- Reason
- 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.
- Recall initiated
- April 10, 2013
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Betamethasone Combination with Lidocaine 1% and Bupivacaine 0.5 % Injection, all strengths and all presentations including a) Betameth combo 6 mg/mL lido 1% bup 0.5% syr; and b) Betameth Combo/Lidocaine 1%/ Bupivacaine 0.5% Syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
by FVS Holdings, Inc. dba. Green Valley Drugs
- Reason
- 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.
- Recall initiated
- April 10, 2013
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Betamethasone Sodium Phosphate Injection, all strengths and all presentations including 6 mg/2 mL PF and 6 mg/mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
by FVS Holdings, Inc. dba. Green Valley Drugs
- Reason
- 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.
- Recall initiated
- April 10, 2013
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
BET-ACE-LIDO-6-2 Injection, all strengths and all presentations including 7 mL syringe and Betameth Combo 6 mg/mL Lidocaine 2% Syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
by FVS Holdings, Inc. dba. Green Valley Drugs
- Reason
- 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.
- Recall initiated
- April 10, 2013
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Betamethasone Combination Injection, all strengths and all presentations including a) Beta combo 6 mg/mL, 3 mL, b) Betameth_Combo_PF-6-2 Syr, and c) Betamethasone Combo 6 mg/mL Syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
by FVS Holdings, Inc. dba. Green Valley Drugs
- Reason
- 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.
- Recall initiated
- April 10, 2013
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
B-Complex Injection, all strengths and all presentations including a) B-Complex Injection 30 mL; b) B-Complex PF 2 mL; c) B-Complex Plus-100; d) B-Complex_B12_30 mL; e) B-Complex-50-Methyl-30-Lido 30 mL; f) B-CompSuper-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
by FVS Holdings, Inc. dba. Green Valley Drugs
- Reason
- 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.
- Recall initiated
- April 10, 2013
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Bacteriostatic Water for Injection, all presentations including 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
by FVS Holdings, Inc. dba. Green Valley Drugs
- Reason
- 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.
- Recall initiated
- April 10, 2013
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
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.
by FVS Holdings, Inc. dba. Green Valley Drugs
- Reason
- 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.
- Recall initiated
- April 10, 2013
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Ascorbic Acid Injection, all strengths and all presentations including a) 500 mg/mL, b) corn source 500 mg/mL, c) tapioca 500 mg/mL, d) cassave 500; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
by FVS Holdings, Inc. dba. Green Valley Drugs
- Reason
- 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.
- Recall initiated
- April 10, 2013
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Amikacin Injection, all strengths and all presentations including 50, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
by FVS Holdings, Inc. dba. Green Valley Drugs
- Reason
- 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.
- Recall initiated
- April 10, 2013
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Alpha Lipoic Acid Injection, all strengths and all presentations including 25 mg/mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
by FVS Holdings, Inc. dba. Green Valley Drugs
- Reason
- 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.
- Recall initiated
- April 10, 2013
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Acetylcysteine Injection, all strengths and all presentations including 100 mg/mL in 30 mL vials and 200 mg/mL in 30 mL and 50 mL vials, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
by FVS Holdings, Inc. dba. Green Valley Drugs
- Reason
- 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.
- Recall initiated
- April 10, 2013
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass I
CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister packs, UPC 736211906892; Distributed by: Casanova Distributors, Tucker, GA
by Performance Plus Marketing, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
- Recall initiated
- December 17, 2012
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass I
Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 count blister packs, UPC 610585435915; Distributed By: Mojo Health, Pompano Beach, FL
by Performance Plus Marketing, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
- Recall initiated
- December 17, 2012
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass I
Mojo nights Capsules, Male Sexual Enhancer, supplied in 1 and 5 count blister packs, Distributed By: Mojo Health, Pompano Beach, FL I count blister UPC - 718122119738; 5 count blister UPC - 705105836430;
by Performance Plus Marketing, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
- Recall initiated
- December 17, 2012
- Reported by FDA
- May 22, 2013
- Distribution
- Nationwide
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
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