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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|
|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|
|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|
|PGE 2.5, 150 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.||160 mL||Nationwide||Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.||Martin Avenue Pharmacy, Inc.||20141105||20140827||70||United States||IL||Naperville||Voluntary: Firm Initiated||Class II||Lot Number: 07182014@28, Exp 9/15/2014|
|Hydrochloric acid/water for injection 10% (w/v) packaged in an amber glass dropper bottle, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.||90 mL||Nationwide||Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.||Martin Avenue Pharmacy, Inc.||20141105||20140827||70||United States||IL||Naperville||Voluntary: Firm Initiated||Class II||Lot Number: 04252014@26, Exp 10/22/2014; 07092014@17, Exp 1/5/2015|
|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|