December 25, 2019DrugsFDA
Lannett Company, Inc. recalls Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philad
Hazard: Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
December 25, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-co
Hazard: Failed Dissolution Specifications: High out of specification result observed at stability studies.
December 25, 2019DrugsFDA
Apothecus Pharmaceutical Corp. recalls VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g). NDC 52925-312-14, b) case pack wi
Hazard: Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable
December 25, 2019DrugsFDA
Medisca, Inc. recalls Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packed by Medisca Inc., Plattsburgh, NY 12901
Hazard: Failed Impurities/Degradation Specifications
December 18, 2019DrugsFDA
AuroMedics Pharma LLC recalls Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 088
Hazard: Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
December 18, 2019DrugsFDA
AuroMedics Pharma LLC recalls Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 0881
Hazard: Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
December 18, 2019DrugsFDA
OraLabs, Incorporated recalls Petroleum jelly (White Petrolatum) USP 100%, packaged in a) 1 oz tube (UPC 1182298884), b) 2.5 oz tube (UPC 1182298541),
Hazard: Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes.
December 18, 2019DrugsFDA
SCA Pharmaceuticals, LLC recalls Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09
Hazard: Presence of Foreign Substance: Foreign material found inside the vial (manufacturer).
December 18, 2019DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-62
Hazard: Defective delivery system; product is not foaming or is coming out as liquid.
December 18, 2019DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manu
Hazard: Defective delivery system; product is not foaming or is coming out as liquid.
December 18, 2019DrugsFDA
Preferred Pharmaceuticals, Inc recalls Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), M
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 18, 2019DrugsFDA
Amneal Pharmaceuticals, Inc. recalls Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
December 18, 2019DrugsFDA
Amneal Pharmaceuticals, Inc. recalls Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
December 18, 2019DrugsFDA
Amneal Pharmaceuticals, Inc. recalls Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
December 18, 2019DrugsFDA
Amneal Pharmaceuticals, Inc. recalls Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c).
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
December 18, 2019DrugsFDA
Amneal Pharmaceuticals, Inc. recalls Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
December 18, 2019DrugsFDA
Surgery Pharmacy Services Inc recalls Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Ser
Hazard: Lack of sterility assurance.
December 18, 2019DrugsFDA
Surgery Pharmacy Services Inc recalls Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Serv., 3908 TENN.A
Hazard: Lack of sterility assurance.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 57
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, Ana
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL and Fentanyl Citrate in all strengths, all doses an
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all strengths, all doses and all packaging, Ana
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen in all strengths, all doses and all packaging, Anaz
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Baclofen and Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Morphine Sulfate and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, Anaz
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging AnazaoHealth 5710 H
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL Syringe, An
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Clonidine HCL PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 mg/mL *Compounded 20 mL Syringe (Standard)
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Clonidine HCL and Baclofen and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.