🍔 Food 💊 Drugs 🏥 Medical Devices
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49 Class II

Reason: Crystallization

Hospira Inc. 20150123 Terminated
Distributed: U.S. Nationwide and International: Guam and Singapore.
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KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49 Class II

Reason: Crystallization

Hospira Inc. 20150123 Terminated
Distributed: U.S. Nationwide and International: Guam and Singapore.
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GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724, NDC: 23155-116-01. Class II

Reason: Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

Heritage Pharmaceuticals, Inc. 20150325 Terminated
Distributed: U.S. Nationwide including Puerto Rico.
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Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count Bottles, NDC 0378-0781-91, b) 500 count Bottles, NDC 0378-0781-05, Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, USA. Class III

Reason: Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.

Mylan Pharmaceuticals Inc. 20150311 Terminated
Distributed: Nationwide
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Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of China, Wallcur, San Diego, CA, 92111, USA; Wallcur Practi Products for Clinical Simulation; NDCs 5108-0954-75, 5108-0954-71, 5108-0954-72, 5108-0954-74, 5108-0954-73. Class I

Reason: Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.

Wallcur Incorporated 20150106 Terminated
Distributed: United States including Puerto Rico; and Canada
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MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia. Available in a) 20 mg/10 mL Multi Dose Vial (NDC: 61703-343-18); b) 25 mg/12.5 mL Multi Dose Vial (NDC: 61703-343-65); c) 30 mg/15 mL Multi Dose Vial (NDC: 61703-343-66). Class I

Reason: Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.

Hospira Inc. 20141203 Terminated
Distributed: US: Nationwide including Puerto Rico; Australia, Canada, Cyprus, Egypt, Ireland, Saudi Arabia, Qatar, Oman, Bahrain, and United Kingdom.
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Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceuticals Lt. for Sandoz Inc., Princeton, NJ 08540, NDC 0781-3182-73 and 0781-3182-84 Class II

Reason: Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.

Navinta LLC 20150309 Terminated
Distributed: Nationwide
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Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 --- NDC 68084-214-01(carton) NDC 68084-214-11 (individual dose) Class II

Reason: Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules

American Health Packaging 20150106 Terminated
Distributed: Nationwide
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0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31 Class II

Reason: Lack of Assurance of Sterility; increased complaints received for leaks

Baxter Healthcare Corp 20150323 Terminated
Distributed: Nationwide and Singapore
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Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04 Class II

Reason: Lack of Assurance of Sterility; increased complaints received for leaks

Baxter Healthcare Corp 20150323 Terminated
Distributed: Nationwide and Singapore
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