JANUARY 2013

WEEK ENDING JANUARY 26

Hospira issues a Recall of One Lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 ML, Flexible Containers Due to Non-Sterility

Hospira, Inc. (NYSE: HSP), is recalling one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09. This action is due to one confirmed customer report where a spore-like structured particulate, consistent with mold, was noted in the solution. 

The product is used as a source of water, electrolytes and calories or as an alkalizing agent and is packaged in a 1000 mL flexible container, lot number 05-019-JT, with an expiration date of May 1, 2013. The affected lot was distributed nationwide between June 2011 and January 2012 to wholesalers/distributors, hospitals and pharmacies.

Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-965-5798 between the hours of 8am to 5pm EST, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available.

Freedom Trading Issues a Recall of Super Power

D&S Herbals, LLC, d/b/a Freedom Trading is recalling a product sold as a dietary supplement under the brand name of Super Power. This product was sold between August 2012 and January 2013 nationwide.

Analytical tests conducted by independent labs of Super Power concluded that the products contained trace amounts of sildenafil. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED) making this product an unapproved new drug.

The recalled products are in capsule form, packaged in two (2) count blister packs. The lot and expiration date can be found on the back of the package. The following lot is being recalled: 

Product Batch Lot # EXPIRATION DATES
Super Power L08108 06/2015

We urge consumers who have purchased these products to immediately discontinue their use and contact their physician if they have experienced any problems that may be related to taking this product. The Company is advising consumers to return the product to their place of purchase. Consumers may also return products directly to Freedom Trading. Customers can call the Company at 866-780-6474 Monday through Friday from 9:00 am – 5:00 pm EST for instructions on the return and refund process.

Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Drugs CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88 Lot number 6A007046V, exp 07/12 Class III Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life Teva Pharmaceuticals USA, Inc.
Drugs I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031 N/A Class II Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use. James G. Cole, Inc.
Drugs Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25. Lot #160017A, Exp 04/2013. Class III Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite. Boehringer Ingelheim Roxane Inc
Drugs Prednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 48-count Cartons, b) 45802-303-21, 21-count Cartons, Manufactured by: West-Ward Pharmaceutical Corporation, Eastown, NJ 07724, Distributed by: Perrigo, Allegan, MI 49040. Lot #s: a) 2DV1238, Exp10/13; 2CV0623, 2CV0625, Exp 11/13; b) 2DV1239, Exp 10/13; 2CV0627, Exp 11/13 Class II Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions L. Perrigo Co.
Drugs Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11. Lot #: 310162, Exp 09/14 Class III Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label. Upsher Smith Laboratories, Inc.

 

WEEK ENDING JANUARY 19

Advance Pharmaceutical Issues recall of one Lot (# 12G468) of Ferrous Sulfate Tablets, 325 mg, that may actually contain Meclizine HCl 25 mg tablets

Advance Pharmaceutical Inc. is recalling one lot of Ferrous Sulfate Tablets, 325 mg, Lot 12G468 Exp. 07/14, UPC Barcode 0 0536-5890-01 3. The lot was manufactured and packaged in 100 count bottles by Advance Pharmaceutical Inc. under the label of Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate. A bottle of Ferrous Sulfate Tablets, 325 mg 07-2014, contained Meclizine HCl 25 mg tablets, NDC 0536-3990-01. Taking Meclizine HCl 25 mg as Ferrous Sulfate 325 mg may cause serious side effects to those who consume alcohol or other sedatives, those with a pre-existing CNS disorder, those with imprinted kidney or liver function, the elderly, nursing infants of lactating mothers who received the drug and newborns of mothers who received the drug immediately before childbirth.

Consumers who have the affected lot may contact Advance Pharmaceutical with questions at 631-981-4600, Ext.300 on Monday through Friday between 8:30 am and 4:30 pm ET.

WEEK ENDING JANUARY 12

Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Drugs Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01 Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 & 2002157 Exp. 9/12 Class II Failed USP Content Uniformity Requirements: OOS result reported on retained samples. Mylan LLC.
Drugs Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA All Lot codes Class I Non-Sterility New England Compounding Center
Drugs Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class I Non-Sterility New England Compounding Center
Drugs Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class I Non-Sterility New England Compounding Center
Drugs Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class I Non-Sterility New England Compounding Center
Drugs Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/mL PF Injection, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility New England Compounding Center
Drugs Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01 Lot 100953A, Exp 01OCT2013; Lot 120803A Exp 01DEC2013 Class II Presence of Particulates; may contain glass particles Hospira Inc.
Drugs Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A. LOT # 18262A8 Exp. 09/13 Class II Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets. Abbott Laboratories

 

Mobius Therapeutics, LLC Issues a Recall of Mitosol® (mitomycin for
solution), 0.2 mg/vial, Kit for Ophthalmic Use

Mobius Therapeutics, LLC, St. Louis, MO, is recalling 2 lots of Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use.  The company is taking this action due to the fact that we cannot exclude the possibility that the affected lots may be non-sterile.  These two lots of Mitosol (mitomycin for solution) Kits may contain a strain of yeast on one or more parts in the kit and should be considered non-sterile and unsafe for use.

Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. The user level for this product would be physicians in hospitals and clinics during surgery. Use of these potentially contaminated products could result in serious eye problems/infections, including possible blindness. Mobius has not received any report of adverse events related to this recall. Customers with affected product in their possession should stop using the product immediately and contact Mobius at 1-877-393-6484, Option 2, for safe return of the product.

The impacted product is identified below:

NDC # Lot # Exp Date Product Description
49771-002-01 M098260 08/2013 Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for
Ophthalmic Use
49771-002-01 M086920 08/2013 Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for
Ophthalmic Use

These lots were distributed in the following states:

AL, AR, DE, GA, IL, IN, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, PA, TN, VA, & WI
between the dates of 10/22/2012 and 12/14/2012.

Mobius has contacted all affected customers by phone call, e-mail and written notification and they are arranging for return of unused product and replacing with product from unaffected lots.

Questions may be directed to Mobius by dialing 1-877-EYE-MITO (1-877-393-6486) and pressing option “2”, Monday to Friday, 8:00 am to 5:00 pm CST. 

WEEK ENDING JANUARY 5

Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Drugs Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot HB23111 and HC23111 Class II Subpotent; 9-month stability interval Lloyd Inc. of Iowa
Drugs Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. Lot 1093992 and 1094095, exp. date 9/2012 Class II Subpotent; 9-month stability interval Lloyd Inc. of Iowa
Drugs Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA Lot HF23111 Class II Subpotent; 9-month stability interval Lloyd Inc. of Iowa
Drugs Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. Lot 1094098, exp. date 9/2012 Class II Subpotent; 9-month stability interval Lloyd Inc. of Iowa
Drugs Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR 11T7011A, Exp. Date: 12/2012 Class II Subpotent; 15 month stability Alara Pharmaceutical Co
Drugs Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Welwyn Garden City, AL7 1TW, United Kingdom bulk lot N0019, Expiration Date: 11 2014 Warennummer: 10131968 Chargennummer:NXXXX 2000609D Finished product Lot N0019B01-N0019B12 Class II Lack of Assurance of Sterility; container closure issues with the bulk batch. F. Hoffmann-LaRoche Ltd.