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Product Description Quantity Distribution Reason for Recall Recalling Firm Report Date Initiation Date Days To Report Country State City Voluntary or Mandated Classification Code Info
MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Houston 9265 Katy Dr., Houston, TX ---NDC 42852-907-10 25 bags Texas Subpotent Advanced Pharma Inc. 20180131 20180105 26 United States TX Houston Voluntary: Firm Initiated Not Yet Classified Lot: 12/22/17 1422 108-90710P UD: 3/22/2018
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02 143,250 vials Nationwide Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial. Hospira Inc., A Pfizer Company 20161228 20160804 146 United States IL Lake Forest Voluntary: Firm Initiated Class I Lot # 59064DK, Exp. 11/17
GABA 50MG/ML (PF), 50ML Vials, MEDAUS PHARMACY 110 mL in Vials U.S. Nationwide, Japan, and New Zealand. Lack of Assurance of Sterility Medaus, Inc. 20160720 20160513 68 United States AL Birmingham Voluntary: Firm Initiated Class II Lot #: 160315-14, BUD: 09/11/16
Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvine, CA 92612. UPC 300238335159 Nationwide and Puerto Rico Failed Content Uniformity Specifications. Allergan Sales, LLC 20160713 20160510 64 United States TX Waco Voluntary: Firm Initiated Class II Lot #: 84126, Exp FEB/2017
Phytonadione (Vitamin K) 1 mg/0.1mL Syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 20 syringes Texas Lack of Assurance of Sterility Walgreens Infusion Services 20160106 20151110 57 United States TX San Antonio Voluntary: Firm Initiated Class II All lots within expiry.
Sermorelin/GHRP6 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN 185 ml total volume Nationwide Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America 20150923 20150602 113 United States TN Knoxville Voluntary: Firm Initiated Class II All lots distributed between November 2014 and May 2015; 05072015@31, 7/6/2015; 03232015@11, 5/22/2015; 03302015@44, 5/29/2015; 03272015@16, 5/26/2015; 04222015@81, 6/1/2015; 04032015@15, 6/2/2015; 04142015@9, 6/13/2015; 04232015@11, 6/22/2015; 04272015@42, 6/26/2015; 04292015@86, 6/28/2015
Calcitriol active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada 100 grams Nationwide to compounding pharmacies and research organizations. Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. Attix Pharmaceuticals 20150429 20141114 166 Canada Toronto Voluntary: Firm Initiated Class II All lots repackaged and distributed between 01/05/12 to 02/12/15
Papaverine 12mg/phent 1mg/Pros 9mcq/ml NC Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center 20140312 20131101 131 United States NC Asheville Voluntary: Firm Initiated Class II All lot numbers within expiry.
AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0101-00, UPC 7 88521 12020 8. 145,650 bottles Nationwide Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label. Valeant Pharmaceuticals 20121114 20121015 30 United States NJ Bridgewater Voluntary: Firm Initiated Class III All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12020 8
HYDROXOCOBALAMIN**(VIT B-12) 1000MCG/ML INJECTABLE 30 ML Injectable (4 DIFFERENT PRODUCTS) 7 units Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab 20120822 20120525 89 United States FL Ocala Voluntary: Firm Initiated Class II Rx #'s: 0389887 0399968 0398811