FDA 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.
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
BLUE Diamond PLATINUM Capsules, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By: DH Distribution Los Angeles, CA 90026 1 count blister UPC -608641933543; 5 count blister UPC - 608641932867; 10 count UPC -608641933536
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
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
BLUE Diamond Pill, supplied in 1, 5 and 10 count blister packs, Male Sexual Enhancement, Distributed By: DH Distribution Los Angeles, CA 90026. 1 count blister: UPC 705105524764, 5 count blister: UPC 736211124012, 10 count blister: UPC 736211123916.
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
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By Kretek International, Inc. Moorpark, CA 930210 1 count blister: UPC 705105830735, 5 count blister: UPC 610585435939, 10 count blister: UPC 610585435922.
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
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count blister packs, Distributed By: H & K Nutraceuticals Los Angeles, CA 1 count blister: UPC 094922567611, 5 count blister: UPC 094922567628, 10 count blister: UPC 610585434253.
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
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Mahwah, NJ 07430
by Glenmark Generics Inc., USA
- Reason
- Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for :Glenmark Generics USA Mahwah, NJ 07430
by Glenmark Generics Inc., USA
- Reason
- Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.
- Published
- May 22, 2013
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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