November 1, 2017DrugsFDA
Banner Pharmacy Services, LLC recalls Succinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226,
Hazard: Lack of Assurance of Sterility.
November 1, 2017DrugsFDA
Banner Pharmacy Services, LLC recalls Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Compounding Pharmacy 7300 W Detroit St Chandle
Hazard: Lack of Assurance of Sterility.
November 1, 2017DrugsFDA
Banner Pharmacy Services, LLC recalls OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit
Hazard: Lack of Assurance of Sterility.
November 1, 2017DrugsFDA
Banner Pharmacy Services, LLC recalls Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag, Rx Only, Banner Health Compounding Phar
Hazard: Lack of Assurance of Sterility.
November 1, 2017DrugsFDA
Banner Pharmacy Services, LLC recalls Midazolam HCL 100 mg (1mg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300
Hazard: Lack of Assurance of Sterility.
November 1, 2017DrugsFDA
Banner Pharmacy Services, LLC recalls Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags, Rx Only, Banner Health Compounding Pharmacy 7300 W Det
Hazard: Lack of Assurance of Sterility.
November 1, 2017DrugsFDA
Banner Pharmacy Services, LLC recalls Hydromorphone HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy
Hazard: Lack of Assurance of Sterility.
November 1, 2017DrugsFDA
Banner Pharmacy Services, LLC recalls fentanyl citrate (PF) 1100 mcg (20 mcg/mL) 55 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Ph
Hazard: Lack of Assurance of Sterility.
November 1, 2017DrugsFDA
Banner Pharmacy Services, LLC recalls fentaNYL citrate 1000 mcg (10 mcg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharma
Hazard: Lack of Assurance of Sterility.
November 1, 2017DrugsFDA
Banner Pharmacy Services, LLC recalls ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Det
Hazard: Lack of Assurance of Sterility.
November 1, 2017DrugsFDA
Banner Pharmacy Services, LLC recalls Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx Only, Banner Health Compounding Pharmacy 7
Hazard: Lack of Assurance of Sterility.
October 25, 2017DrugsFDA
The Harvard Drug Group recalls Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Privat
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
October 25, 2017DrugsFDA
RXQ Compounding LLC recalls methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-
Hazard: Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
October 25, 2017DrugsFDA
Deserving Health International Corp recalls Symbio Muc Eye, 0.17 fl.oz. 5mL bottles, Manufactured for and distributed in the US b: Biological Health Group Corp. Bre
Hazard: Lack of Assurance of Sterility
October 25, 2017DrugsFDA
Unichem Pharmaceuticals Usa Inc recalls Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind.
Hazard: Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
October 18, 2017DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-3
Hazard: Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.
October 18, 2017DrugsFDA
United Pharmacy recalls Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Com
Hazard: CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
October 18, 2017DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceutic
Hazard: Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
October 11, 2017DrugsFDA
Vi-Jon, Inc. recalls Magnesium Citrate Oral Solution Cherry Flavor, 1.745 g per fl oz, packaged in 10 fl. oz ( 296 mL) bottles, Labeled as a)
Hazard: Failed Impurities/Degradation Specifications.
October 11, 2017DrugsFDA
Vi-Jon, Inc. recalls Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in 10 fl. oz. (296 mL) bottles, Labeled as a)
Hazard: Failed Impurities/Degradation Specifications.
October 11, 2017DrugsFDA
Inopak Ltd recalls Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD, Ringwood, NJ
Hazard: GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
October 11, 2017DrugsFDA
Inopak Ltd recalls Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Disc Pump, 800 mL Universal Valve, and 1 gall
Hazard: GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
October 11, 2017DrugsFDA
Inopak Ltd recalls Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 100
Hazard: GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
October 11, 2017DrugsFDA
Pfizer Inc. recalls Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutan
Hazard: CGMP Deviations: Firm failed to control impurity for color change at the API stage.
October 4, 2017DrugsFDA
Sandoz Inc recalls Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (N
Hazard: Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
October 4, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia BBG3000, Malt
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.
October 4, 2017DrugsFDA
Pfizer Inc. recalls Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045
Hazard: Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
October 4, 2017DrugsFDA
RemedyRepack Inc. recalls Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021-00), Ref: 33631 and b)
Hazard: Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.
September 27, 2017DrugsFDA
Genentech, Inc. recalls Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water
Hazard: Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
September 27, 2017DrugsFDA
Medisca, Inc. recalls Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient, packaged in a) 100 g jar (NDC 38779-0989
Hazard: CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.