🍔 Food 💊 Drugs 🏥 Medical Devices
Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045, NDC 0456-3407-33 Class III

Reason: Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.

Forest Pharmaceuticals Inc 20131113 Terminated
Distributed: Nationwide and Puerto Rico.
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CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH Class II

Reason: CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension.

Central Shared Services dba Parallon 20130823 Terminated
Distributed: GA, KY, TN
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Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel by Teva Pharmaceuticals Ind., LTD, Jerusalem, Israel, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA. NDC #0093-7259-56 Class II

Reason: Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets.

Teva Pharmaceuticals USA, Inc. 20131108 Terminated
Distributed: Nationwide
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Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles) Class II

Reason: Failed Tablet/Capsule Specifications: Broken tablets

Actavis Inc 20130322 Terminated
Distributed: Nationwide
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Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2 Class III

Reason: Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval

Greenstone Llc 20131104 Terminated
Distributed: US Nationwide (including PR)
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Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66 Class III

Reason: Failed Dissolution Specification; 8 hr stability timepoint

Pfizer Inc. 20131104 Terminated
Distributed: US nationwide (including PR)
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50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02 Class I

Reason: Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.

Baxter Healthcare Corp. 20131118 Terminated
Distributed: Nationwide, Saudi Arabia and Colombia
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Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393. Class II

Reason: Marketed without an Approved NDA/ANDA.

Insight Instruments, Inc. 20130424 Terminated
Distributed: Nationwide and Puerto Rico
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Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML Class II

Reason: Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.

Fusion Pharmaceuticals, LLC 20130508 Terminated
Distributed: CA
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Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc., NDC 0264-3193-11 Class I

Reason: Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.

B. Braun Medical Inc 20131015 Terminated
Distributed: Nationwide
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