🍔 Food 💊 Drugs 🏥 Medical Devices
Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01 Class II

Reason: Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin

Sandoz Incorporated 20131022 Terminated
Distributed: Nationwide
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Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g inhaler, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Delivery Systems, Northridge, CA 91324, NDC 59310-210-12, UPC 3 59310 21012 9. Class III

Reason: Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.

Teva Pharmaceuticals USA 20131204 Terminated
Distributed: Nationwide and Puerto Rico
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0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1165-02 Class I

Reason: Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.

Hospira Inc. 20130712 Terminated
Distributed: Nationwide
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0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1159-02 Class I

Reason: Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.

Hospira Inc. 20130712 Terminated
Distributed: Nationwide
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FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173 NDC 63323-184-11 Class III

Reason: Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point

Fresenius Kabi USA, LLC 20131206 Terminated
Distributed: Nationwide, Puerto Rico, Canada, New Zealand
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PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied in 1 capsule per blister pack, Distributed by MSH Distribution LLC Class I

Reason: Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil

Fabscout Entertainment, Inc 20130814 Terminated
Distributed: CA, FL and UT
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72HP MAXIMUM POTENCY MALE SEXUAL ENHANCEMENT, Dietary Supplement, supplied in 1 capsule per blister pack, Distributed by: 72HP, Inc. Weston, FL Class I

Reason: Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil

Fabscout Entertainment, Inc 20130814 Terminated
Distributed: CA, FL and UT
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Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang Health Medicine Co.,Ltd. Address: No. 98, Min zu Road, Lhasa Class I

Reason: Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil

Fabscout Entertainment, Inc 20130814 Terminated
Distributed: CA, FL and UT
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Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottle, sold under the following labels: (a) CVS pharmacy brand LUBRICANT EYE DROPS FOR MILD TO MODERATE DRY EYE, Distributed by CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 053357 7 and UPC 0 50428 27364 7; (b) equate brand Lubricant Eye Drops, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 03420 3; and (c) up & up brand lubricant eye drops, Dist. by Target Corporation, Minneapolis, MN 55403, UPC 8 58961 79102 0. Class I

Reason: Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the preservative used in the lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution may not be effective through expiry.

Altaire Pharmaceuticals, Inc. 20130906 Terminated
Distributed: Nationwide
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Multi-Mineral capsules, 200-count bottles, labeled in part as Healthy Life Chemistry, By Purity First, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735; 1-800-696-7017 Class I

Reason: Marketed Without An Approved NDA/ANDA: New York State Department of Health analysis of this product found it to contain undeclared steroid-like substances making it an unapproved new drug.

Healthy Life Chemistry Inc dba Purity First 20130731 Terminated
Distributed: Approximately 30% of all finished products were sold to customers in interstate to include but may not be limited to NY, NJ & CT via UPS. Products are promoted and sold directly to customers at Healthy Life Chemistry's retail store at 13A Lucon Drive in Deer Park, NY, on the company website (www.purityfirst.com), and are available at the health food store, Total Health, located at 120 Rte 110, Farmingdale, NY (www.totaldiscountvitamins.com).
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