🍔 Food 💊 Drugs 🏥 Medical Devices
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product L5B4826, NDC 0941-0409-07 Class II

Reason: Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.

Baxter Healthcare Corp. 20130724 Terminated
Distributed: Nationwide and Puerto Rico
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Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laboratories, Mason OH, 45040, USA, Mfd by: Torrent Pharmaceuticals Ltd., Indrad-382 721, Dist. Mehsana India, NDC 66993-463-30 Class II

Reason: Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application.

Torrent Pharma Inc 20130722 Terminated
Distributed: Nationwide
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Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA Class II

Reason: Failed Impurity/Degradation Specification; "Related Compound C"

Actavis South Atlantic LLC 20130515 Terminated
Distributed: Nationwide
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Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA Class I

Reason: Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction (ED) making this product an unapproved new drug.

Green Planet Inc 20130311 Terminated
Distributed: Nationwide.
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DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg) liquicaps and NyQuil Sinex NightTime Sinus Relief (acetaminophen 325 mg, doxylamine succinate 6.25 mg, and phenylephrine HCl 5 mg) liquicaps Combopack, each 48-count liquicaps per carton contains 32 DayQuil Sinex DayTime Liquicaps and 16 NyQuil Sinex NightTime Liquicaps per carton, Made In Canada, Dist. by Procter & Gamble, Cincinnati, OH 45202, UPC 3 23900 01454 1. Class II

Reason: Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed liquicaps within the blisters.

Procter & Gamble Co 20130703 Terminated
Distributed: Nationwide
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Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropine Sulfate 0.0194 mg, Scopolamine Hydrobromide 0.0065 mg 30-count bottle (NDC 54868-0031-04), Rx only, Repackaged and distributed by Physicians Total Care, Inc. Tulsa, OK 74146. Class II

Reason: Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.

Physicians Total Care, Inc. 20130617 Terminated
Distributed: GA
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Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07 Class II

Reason: Failed Impurities/Degradation Specifications: unspecified degradation product

Warner Chilcott US LLC 20130517 Terminated
Distributed: Nationwide
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West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724 Class II

Reason: Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.

West-Ward Pharmaceutical Corp. 20130516 Terminated
Distributed: Nationwide
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West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724 Class II

Reason: Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.

West-Ward Pharmaceutical Corp. 20130516 Terminated
Distributed: Nationwide
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Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737-05), Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA92880. Class III

Reason: Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.

Watson Laboratories Inc 20130719 Terminated
Distributed: Nationwide
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