🍔 Food 💊 Drugs 🏥 Medical Devices
Mangiacotti - Pomegranate Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005344, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703. Class II

Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.

Mangiacotti 20131227 Terminated
Distributed: Nationwide
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Mangiacotti - Clementine Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005337, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703. Class II

Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.

Mangiacotti 20131227 Terminated
Distributed: Nationwide
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Mangiacotti - Ocean Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005320, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703. Class II

Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.

Mangiacotti 20131227 Terminated
Distributed: Nationwide
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Mangiacotti - Lavender Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005313, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703 . Class II

Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.

Mangiacotti 20131227 Terminated
Distributed: Nationwide
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Mangiacotti - Lemon Verbena Hand Sanitizer Spray, alcohol free, 0.5 fl. Oz., 15 mL spray bottle, UPC 870678005306, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703. Class II

Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.

Mangiacotti 20131227 Terminated
Distributed: Nationwide
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Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134, NDC 24658-0292-05 Class II

Reason: Defective container: Product distributed without inner seal on bottles.

Blu Pharmaceuticals Inc 20140313 Terminated
Distributed: NJ, UT, IL and CT
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Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134 NDC 24658-290-05 Class II

Reason: Defective container: Product distributed without inner seal on bottles.

Blu Pharmaceuticals Inc 20140313 Terminated
Distributed: NJ, UT, IL and CT
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Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1. Class II

Reason: Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.

Wockhardt Usa Inc. 20140401 Terminated
Distributed: Nationwide
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Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1. Class III

Reason: Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.

Apotex Inc. 20140320 Terminated
Distributed: Nationwide and Puerto Rico.
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Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl oz Bottles, liquid. Labeled A) aaron health KIDS, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262. UPC: 7 15256 72204 9. B) FAMILY wellness, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105. UPC: 0 32251 03394 0. C) Good Neighbor Pharmacy. Distributed By: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087. NDC: 24385-121-25. D) Pedia Care. Distributed by Medtech Products Inc., Irvington, NY 10533. UPC: 8 14832 01354 7. E) Quality Choice. Distributed by Quality Choice, Novi, MI 48376-0995. NDC: 63868-0368-04. F) Safeway. Distributed by Safeway Inc. P.O. Box 99, Pleasanton, CA 94566. NDC: 21130-152-04. G) Well at Walgreens. Distributed By: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0152-04. Class III

Reason: Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.

P&L Developments, LLC 20140415 Terminated
Distributed: Nationwide in US
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