FDA Recall
Terminated
Historical recordClass II
Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32
by Nostrum Laboratories, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- June 22, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
by Well Care Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- Published
- June 15, 2016
- Distribution
- NV
View recall →
FDA Recall
Terminated
Historical recordClass II
M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
by Well Care Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- Published
- June 15, 2016
- Distribution
- NV
View recall →
FDA Recall
Terminated
Historical recordClass II
ESTRADIOL VALERATE 20MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
by Well Care Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- Published
- June 15, 2016
- Distribution
- NV
View recall →
FDA Recall
Terminated
Historical recordClass II
ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
by Well Care Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- Published
- June 15, 2016
- Distribution
- NV
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FDA Recall
Terminated
Historical recordClass I
TruTrim (product not labeled)
by Novacare, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
- Published
- June 15, 2016
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
Thin and Slim Burn Fat Now Dietary Supplement packaged in 90 capsule containers. http://www.secretsofherbs.com. Made in the USA.
by Novacare, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
- Published
- June 15, 2016
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM
by Reesna, Inc
- Reason
- Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.
- Published
- June 15, 2016
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
by Well Care Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- Published
- June 15, 2016
- Distribution
- NV
View recall →
FDA Recall
Terminated
Historical recordClass II
ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
by Well Care Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- Published
- June 15, 2016
- Distribution
- NV
View recall →
FDA Recall
Terminated
Historical recordClass II
CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
by Well Care Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- Published
- June 15, 2016
- Distribution
- NV
View recall →
FDA Recall
Terminated
Historical recordClass II
QUAD-MIX #3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
by Well Care Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- Published
- June 15, 2016
- Distribution
- NV
View recall →
FDA Recall
Terminated
Historical recordClass II
VITAMIN B COMPLEX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
by Well Care Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- Published
- June 15, 2016
- Distribution
- NV
View recall →
FDA Recall
Terminated
Historical recordClass II
VITAMIN B COMPLEX # 1; packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
by Well Care Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- Published
- June 15, 2016
- Distribution
- NV
View recall →
FDA Recall
Terminated
Historical recordClass II
VANCOMYCIN 50MG/ML OPHTH SOLUTION; packaged in 10mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
by Well Care Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- Published
- June 15, 2016
- Distribution
- NV
View recall →
FDA Recall
Terminated
Historical recordClass II
TRI-MIX # 6, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
by Well Care Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- Published
- June 15, 2016
- Distribution
- NV
View recall →
FDA Recall
Terminated
Historical recordClass II
TRI-MIX # 4, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
by Well Care Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- Published
- June 15, 2016
- Distribution
- NV
View recall →
FDA Recall
Terminated
Historical recordClass II
TRI-MIX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
by Well Care Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- Published
- June 15, 2016
- Distribution
- NV
View recall →
FDA Recall
Terminated
Historical recordClass II
TRI-MIX # 2, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
by Well Care Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- Published
- June 15, 2016
- Distribution
- NV
View recall →
FDA Recall
Terminated
Historical recordClass II
TRI-MIX # 1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
by Well Care Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- Published
- June 15, 2016
- Distribution
- NV
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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