Drug and pharmaceutical recalls
17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-06-22FDA-DrugNostrum Laboratories, Inc.Class IINitrofurantoin 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
Failed Dissolution Specifications
- 2016-06-22FDA-DrugGenzyme Corporation / Genzyme BiosurgeryClass IIIHectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1
Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IICLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIQUAD-MIX #3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIVITAMIN B COMPLEX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIVITAMIN B COMPLEX # 1; packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIVANCOMYCIN 50MG/ML OPHTH SOLUTION; packaged in 10mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IITRI-MIX # 6, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IITRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IITRI-MIX # 4, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IITRI-MIX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IITRI-MIX # 2, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IITRI-MIX # 1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IITESTOSTERONE CYPIONATE 200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IITESTOSTERONE CYPIONATE 175MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IITESTOSTERONE CYPIONATE 150MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IITESTOSTERONE CYPIONATE 10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IITESTOSTERONE CYPIONATE 100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IISUPER TRI-MIX #4, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IISUPER TRI-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIQUAD-MIX #4 (MOD), packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIQUAD-MIX #2, packaged in 5mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIQUAD-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIPHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID- 5%/4.75%, packaged in 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIPHENYLEPHERINE 0.5%, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIMYERS' COCKTAIL, packaged in 37 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIMETHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIMETHYLCOBALAMIN 5MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
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