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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
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
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
Hydrocortisone Sodium Succinate 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 6100 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
Dexmedetomidine HCI 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 130 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
Quad mix 1, 12 mg/1 mg/10 mcg/0.15 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. 60 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: 06052014@24, Exp 9/12/2014
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.
Super Trimix #1 Inj MDV, 12 ml Penile Injection, 90 day expiration, 1 Nationwide Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Nora Apothecary and Alternative Therapies, Inc. 20130605 20130422 44 United States IN Indianapolis Voluntary: Firm Initiated Class II All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
All Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com Nationwide Japan GMP Deviations New England Compounding Center 20121121 20121006 46 United States MA Framingham Voluntary: Firm Initiated Class II All lot codes