🍔 Food 💊 Drugs 🏥 Medical Devices
All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712 Class II

Reason: Lack of Assurance of Sterility; potential for mold contamination

Med Prep Consulting, Inc. 20130314 Terminated
Distributed: Press States Nationwide. Distribution List indicates the following: DE, FL, IL, IN, ME, MI, NJ, PA, TX, and VA
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Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712 Class I

Reason: Non-Sterility; mold contamination

Med Prep Consulting, Inc. 20130314 Terminated
Distributed: Press States Nationwide. Distribution List indicates the following: DE, FL, IL, IN, ME, MI, NJ, PA, TX, and VA
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Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01), 3 kits per box (NDC 49771-002-03), Rx only, Manufactured for: Mobius Therapeutics, LLC, 4041 Forest Park Avenue, St. Louis, MO 63108 USA. Class I

Reason: Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.

Mobius Therapeutics LLC 20130103 Terminated
Distributed: Nationwide and Military and Government Consignees
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Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and Reconstitution. a) Five vials kits: NDC# 45567-0555-1, b) Thirty vials kits: NDC# 45567-0555-2, Rx Only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821 Class III

Reason: Presence of Particulate Matter; particulate found in retain samples

Pharmalucence, Inc. 20130530 Terminated
Distributed: Nationwide & Bahamas, Barbados, Bermuda, Japan
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Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin Class III

Reason: Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.

Bayer HealthCare Pharmaceuticals Inc. 20130613 Terminated
Distributed: NY, CA
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Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0. Class I

Reason: Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.

Apotex Corp. 20130318 Terminated
Distributed: Nationwide
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Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15 Class II

Reason: Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.

Sandoz Incorporated 20130621 Terminated
Distributed: Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.
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Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01. Class II

Reason: Subpotent Drug; 15-month stability test station

Fresenius Kabi USA, LLC 20130624 Terminated
Distributed: Nationwide and Puerto Rico
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Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960. Class III

Reason: Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.

Teva Pharmaceuticals USA, Inc. 20130618 Terminated
Distributed: Nationwide
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QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01 Class II

Reason: Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.

American Health Packaging 20121010 Terminated
Distributed: Nationwide
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