DL DrugLabelsHubFDA Drug Label Lookup

FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
Phenylephrine-cyclopentolate, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Pap 300 mg-phent 10 mg-prost 100 mcg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Ophthalmic dilation gel (MAR), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Ophthalmic dilation gel, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Mitomycin (modified) 0.02% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Mitomycin 0.04% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Methylcobalamin 12.5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Methylcobalamin 1250 mcg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Methionine/Choline/Inositol/ B-12, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Medroxyprogesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Medroxyprogesterone 150 mg/ml,Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Latanoprost 0.025% eye drop, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Laser ophthalmic drops, 12 mL bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Itraconazole 1% eye ointment, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Injection vehicle, 120 ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Hydroxyprogesterone 250 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
HCG 500 units/ml, 10 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
HCG 2000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
HCG 1000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Gentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Estradiol Valerate 30 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Estradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Estradiol Cypionate 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Diazepam 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Cyclosporine 2% ophthalmic, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Cyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Cataract drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Acetylcysteine 2 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Acetylcysteine 20 % solution, 100 ml bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Acetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Clinical Specialties Compounding Pharmacy Class II Terminated 20130710
Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA 1910, NDC 0046-0975-11 Pfizer Inc. Class III Terminated 20130710
Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA, NDC 0046-0875-11 Pfizer Inc. Class III Terminated 20130710
Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48 Baxter Healthcare Corp. Class II Terminated 20130710
Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11); b) 2B1302- 100mL in Viaflex Quad Pack (NDC 0338-0049-18); c) 2B1306- 50 mL in Viaflex Single Pack (NDC 0338-0049-41; d) 2B1307- 100mL in Viaflex Single Pack (NDC 0338-0049-48); e) 2B1308- 50 ML in Viaflex Multi Pack (NDC 0338-0049-31); f) 2B1309- 100mL in Viaflex Multi Pack (NDC 0338-0049-38), Rx Only, Baxter, Deerfield, IL 60015 Baxter Healthcare Corp. Class II Terminated 20130710
Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL, Rx Only, Baxter, Deerfield, IL 60015 Baxter Healthcare Corp. Class II Terminated 20130710
Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-04), b) Product code 2B0953: 1000 USP Units, Viaflex Plus Container, 500 mL (NDC 0338-0431-03), Baxter, Deerfield, IL 60015 Baxter Healthcare Corp. Class II Terminated 20130710
5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b) 100 mL (NDC 0338-0017-38), Baxter, Deerfield, IL 60015 Baxter Healthcare Corp. Class II Terminated 20130710
0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC 0338-0553-18), Rx Only, Baxter, Deerfield, IL 60015 Baxter Healthcare Corp. Class II Terminated 20130710
0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11 Baxter Healthcare Corp. Class II Terminated 20130703
INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 mL), No Epinephrine, Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com. Indelicare LLC Class II Terminated 20130703
INK-EEZE Tattoo Numbing Spray, 2 oz. (59 mL), Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com Indelicare LLC Class II Terminated 20130703
Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2 Kareway Product Inc Class II Terminated 20130703
0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045 Hospira Inc. Class II Terminated 20130703
1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7974-08 Hospira Inc. Class II Terminated 20130703
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08 Hospira Inc. Class II Terminated 20130703
20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045 Hospira Inc. Class II Terminated 20130703
5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48 Hospira Inc. Class II Terminated 20130703
5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045 Hospira Inc. Class II Terminated 20130703
0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7132-02 Hospira Inc. Class II Terminated 20130703
70% Dextrose Injection USP, 2000 mL, Rx Only, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7120-07 Hospira Inc. Class II Terminated 20130703