🍔 Food 💊 Drugs 🏥 Medical Devices
Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826. Class II

Reason: Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.

Baxter Healthcare Corp. 20141110 Terminated
Distributed: Nationwide
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Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568. Class II

Reason: CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.

Spectrum Laboratory Products 20140718 Terminated
Distributed: U.S.: California.
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Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx only, Manufactured by Hospira, Inc. Lake Forest, IL 60045, NDC 0409-6533-01. Class III

Reason: Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.

Hospira Inc. 20141107 Terminated
Distributed: Nationwide.
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LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540. NDC 42571-110-10 Class II

Reason: Failed Content Uniformity Specifications; Dry mix failed blend uniformity.

Micro Labs Usa, Inc S 20140922 Terminated
Distributed: U.S. Including: New York
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Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sodium), 0.9% Benzyl alcohol in water for injection, Rx Only, Compounded Medication, ABRAMS ROYAL Compounding Pharmacy, Dallas, TX Class I

Reason: Non-Sterility; contract laboratory identified Staphylococcus warneri in the product

Abrams Royal Pharmacy 20130513 Terminated
Distributed: Nationwide
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Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64 u/mL, supplied in 11 mL Sterile Syringes, Rx only, Compounded med, Single use only, (Red Block) ABRAMS ROYAL Compounding Pharmacy, Dallas, TX Class I

Reason: Non-Sterility

Abrams Royal Pharmacy 20130419 Terminated
Distributed: Texas
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Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231. Class I

Reason: Non-Sterility: The firm's contract testing laboratory found sterility failures.

Abrams Royal Pharmacy 20130531 Terminated
Distributed: Two hospitals in Dallas, TX
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Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121 Class II

Reason: Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

Prometheus Laboratories Inc. 20141022 Terminated
Distributed: Nationwide
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Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by Contract Packaging Resources, Inc 8009 Industrial Village Road Greensboro, NC 27409 Distributed by Greenbrier International, Inc Chesapeake, VA 23320 Class II

Reason: Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets, USP

Contract Packaging Resources Inc. 20141010 Terminated
Distributed: Nationwide
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HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01 Class III

Reason: Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.

Fresenius Kabi USA LLC 20140414 Terminated
Distributed: Nationwide and Puerto Rico
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