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ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02 Class II

Reason: Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

Fresenius Kabi USA, LLC 20120927 Terminated
Distributed: U.S. Nationwide Including Puerto Rico
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MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25. Class II

Reason: Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

Fresenius Kabi USA, LLC 20120927 Terminated
Distributed: U.S. Nationwide Including Puerto Rico
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Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61 Class II

Reason: Lack of Assurance of Sterility; improperly crimped fliptop vials

Hospira Inc. 20141203 Terminated
Distributed: Nationwide
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Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41. Class II

Reason: Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.

Baxter Healthcare Corp. 20140424 Terminated
Distributed: Nationwide
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Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle (NDC 0069-5800-60), Rx Only, Manufactured by Pfizer Labs, Division of Pfizer, Inc., NY, NY 10017. Class II

Reason: Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.

Pfizer Inc. 20141203 Terminated
Distributed: Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.
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Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01 Class III

Reason: Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.

Sandoz Incorporated 20141205 Terminated
Distributed: AZ
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GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20 Class II

Reason: Defective Container: Vials may be missing stoppers.

Fresenius Kabi USA, LLC 20141112 Terminated
Distributed: Nationwide and Puerto Rico
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BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01 Class III

Reason: Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.

Zydus Pharmaceuticals USA Inc 20140924 Terminated
Distributed: US Nationwide including Puerto Rico
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candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92 Class III

Reason: Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.

Sandoz, Inc 20141002 Terminated
Distributed: Nationwide
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Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7990-09. Class II

Reason: Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Hospira Inc. 20141014 Terminated
Distributed: Nationwide, Puerto Rico, and U.S. Virgin Islands.
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