🍔 Food 💊 Drugs 🏥 Medical Devices
Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Class II

Reason: Failed dissolution specifications; 18 month CRT

Amneal Pharmaceuticals of New York, LLC. 20130817 Terminated
Distributed: IL, NH, NJ, NY, OH, RI, TN
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Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL sizes, Fallon Wellness Pharmacy, Latham, NY 12110. Class II

Reason: Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility assurance concerns based on testing of this lot by a third party lab, indicating that test results reported as passing sterility may have been inaccurate.

Fallon Wellness Pharmacy Llc 20130905 Terminated
Distributed: NY & ME
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Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25 Class II

Reason: Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.

Nephron Pharmaceuticals Corp. 20131002 Terminated
Distributed: Nationwide and Puerto Rico
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Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04. Class III

Reason: Subpotent

Tolmar, Inc. 20130923 Terminated
Distributed: Nationwide
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GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 16 fl. oz. (NDC 58552-125-16) --- Manufactured for: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00716 Class III

Reason: Subpotent; phenylephrine HCl

Hi-Tech Pharmacal Co., Inc. 20130904 Terminated
Distributed: Puerto Rico
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Concentrated Motrin (ibuprofen) Infants' Drops Oral Suspension, Original Berry Flavor 1/2 fl oz bottles, 50 mg per 1.25ml, Distributed by McNeil Consumer Healthcare, Fort Washington, PA. Class II

Reason: Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed

Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc. 20130906 Terminated
Distributed: Nationwide.
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Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., Princeton NJ, 08540, NDC 0781-1407-01. Class III

Reason: Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.

Sandoz Incorporated 20130925 Terminated
Distributed: Nationwide
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Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 Tablet/Blister Card (NDC 52544-287-54), Manufactured by Watson Laboratories Inc, 132 Business Center Drive, Corona, CA 92880. Class II

Reason: Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.

Watson Laboratories Inc 20130923 Terminated
Distributed: US. No international. NATIONWIDE
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0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045 Class II

Reason: Lack of Assurance of Sterility; potential for vial breakage

Hospira Inc. 20130905 Terminated
Distributed: Nationwide and Guam and Abu Dhabi
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Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA, NDC 0591-0825-01 Class II

Reason: Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.

Watson Laboratories Inc 20130913 Terminated
Distributed: Nationwide
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