Drug Recall Enforcement Reports

What are the Drug Enforcement Reports?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.

The Drug Enforcement Reports included in this listing was last updated on November 24, 2022 and include a total of 14663 recall reports.

Recall Number Initiation Date Product Description Recall Reason Recall Firm / Quantity Recall Classification Status
D-0025-202310-18-2022Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill needle, NDC 50242-078-55; and b) carton labeled as Susvimo Ocular Implant with Insertion Tool Assembly, containing One carrier with implant and One insertion Tool, UDI 81004259001, GTIN 00810042590014, Rx only, Genentech, Inc., A Member of the Roche Group, South San Francisco, CA 94080-4990.
Package NDCs: 50242-078-12; 50242-078-55; 8100425900; 0081004259
Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.Genentech Inc / 452 vials and implantsClass IIIOngoing
D-0024-202310-18-2022Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India; NDC 62756-970-83
Package NDCs: 62756-969-83; 62756-969-64; 62756-970-83; 62756-970-64
Presence of Foreign SubstanceSUN PHARMACEUTICAL INDUSTRIES INC / Class IIOngoing
D-0015-202310-11-20220.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
Package NDCs: 49230-300-10
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.Fresenius Medical Care Holdings, Inc. / 16,006 cases of twelve bags eachClass IIOngoing
D-0014-202310-11-2022NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT PHENYLEPHRINE HCl/ NASAL DECONGESTANT Maximum Strength Decongestant Free DISTRIBUTED BY: WALGREENS CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com
Package NDCs: 0363-6171-09
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mgLNK International, Inc. / 66,384 boxes of twenty tablets eachClass IIIOngoing
D-0033-202310-07-2022GLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 1 droptainerClass IIOngoing
D-0047-202310-07-2022PAPAVERINE HCL STOCK SOLUTION 30MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 28 vialsClass IIOngoing
D-0049-202310-07-2022PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150MG/5MG/10MCG/VIAL SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 1 vialClass IIOngoing
D-0040-202310-07-2022MOXIFLOXACIN PRESERVATIVE FREE SYR, 0.15 mg/0.1 mL, Sterile Solution, 1 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 106 syringesClass IIOngoing
D-0044-202310-07-2022PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 75MG/2.5MG/50MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 1 vialClass IIOngoing
D-0037-202310-07-2022MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 40 vialsClass IIOngoing
D-0026-202310-07-2022ACETYLCYSTEINE OPTH 10% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 1 droptainerClass IIOngoing
D-0043-202310-07-2022PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 150MG/10MG/100MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 1 vialClass IIOngoing
D-0055-202310-07-2022TALC, STERILE POWDER, 5 GM vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 1 vialClass IIOngoing
D-0031-202310-07-2022CEFUROXIME INTRAVITREAL SYR 1MG/0.1ML Solution in 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 460 syringesClass IIOngoing
D-0046-202310-07-2022PAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 242 vialsClass IIOngoing
D-0038-202310-07-2022METHYLCOBALAMIN PF 1 ML Injection Solution 5,000 MCG/ML Solution, 1 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 514 vialsClass IIOngoing
D-0027-202310-07-2022ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 2 droptainersClass IIOngoing
D-0041-202310-07-2022PAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 2 vialsClass IIOngoing
D-0034-202310-07-2022LAURETH-9 INJ 2% Solution, 30 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 3 vialsClass IIOngoing
D-0057-202310-07-2022VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 1 droptainerClass IIOngoing
D-0042-202310-07-2022PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 56 vialsClass IIOngoing
D-0050-202310-07-2022PHENTOLAMINE 10MG/ML INJECTION, 10MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 10 vialsClass IIOngoing
D-0054-202310-07-2022SERUM TEARS IN NSAL 20% OPTH SOLUTION, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 45 droptainersClass IIOngoing
D-0058-202310-07-2022Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., Made in Italy, NDC: 67457-246-00 (syringe), 67457-246-01 (carton).
Package NDCs: 67457-239-00; 67457-239-01; 67457-245-00; 67457-245-01; 67457-246-00; 67457-246-01
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.Viatris Inc / 22400 syringesClass IOngoing
D-0029-202310-07-2022BRILLIANT BLUE G, 0.04% Solution, 2 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 86 vialsClass IIOngoing
D-0048-202310-07-2022PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150/5/50MCG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 5 vialsClass IIOngoing
D-0051-202310-07-2022PRED ACETATE / GATIFLOXACIN 1% / 0.5% SUSP, 10 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 378 droptainersClass IIOngoing
D-0053-202310-07-2022SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 800.5 mL in unit dose vialsClass IIOngoing
D-0039-202310-07-2022MITOMYCIN INJECTION 0.375 mg/mL SYR, 0.375 mg/mL solution, 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 185 syringesClass IIOngoing
D-0036-202310-07-2022LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution, 10 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 7 syringesClass IIOngoing
D-0028-202310-07-2022AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 168 droptainersClass IIOngoing
D-0035-202310-07-2022LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution, 3 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 389 syringesClass IIOngoing
D-0052-202310-07-2022PROSTAGLANDIN E1 INJECTION SOLUTION 500MCG/ML SOLUTION, 1 ML vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 50 vialsClass IIOngoing
D-0045-202310-07-2022PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 90MG/3MG/29.4MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 2 vialsClass IIOngoing
D-0030-202310-07-2022CEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution, 0.5 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 12 syringesClass IIOngoing
D-0056-202310-07-2022VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 12 syringesClass IIOngoing
D-0032-202310-07-2022CYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.Pharmacy Plus, Inc. dba Vital Care Compounder / 67 bottlesClass IIOngoing
D-0012-202310-06-2022Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA, NDC 51407-322-30
Package NDCs: 51407-322-30; 51407-323-30; 51407-323-60; 51407-323-01
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).Golden State Medical Supply Inc. / Class IIOngoing
D-0011-202310-06-2022Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60), c) 100-count bottle (NDC 51407-323-01), Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA.
Package NDCs: 51407-322-30; 51407-323-30; 51407-323-60; 51407-323-01
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).Golden State Medical Supply Inc. / Class IIOngoing
D-0021-202310-05-2022Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90
Package NDCs: 65862-161-90; 65862-162-30; 65862-162-90; 65862-163-90
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.Aurobindo Pharma USA Inc. / 9504 bottlesClass IIOngoing
D-0022-202310-04-20228.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1
Package NDCs: 51754-5001-5; 51754-5001-4; 51754-5011-4; 51754-5002-5; 51754-5012-4; 51754-5001-1
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administrationExela Pharma Sciences LLC / 2,123,040 vialsClass IOngoing
D-0023-202310-04-20228.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
Package NDCs: 72572-740-20
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administrationExela Pharma Sciences LLC / 148,920Class IOngoing
D-0020-202309-30-2022Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 55150-232-10 (carton)NDC 55150-232-00 (syringe)
Package NDCs: 55150-230-00; 55150-230-02; 55150-230-10; 55150-231-00; 55150-231-02; 55150-231-10; 55150-232-00; 55150-232-02; 55150-232-10; 55150-233-00; 55150-233-02; 55150-233-10
Subpotent Drug: Out of specification for assayAuroMedics Pharma LLC / 11,520 unitsClass IIOngoing
D-0018-202309-30-2022Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01
Package NDCs: 66689-406-01; 66689-406-10
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.VistaPharm, Inc. / 1980 cupsClass IIOngoing
D-0010-202309-30-2022Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7
Package NDCs: 50742-317-25
Out of specification for related substances (impurities).Ingenus Pharmaceuticals Llc / 6176 bottlesClass IIOngoing
D-1550-202209-29-2022Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-168-48; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials per carton, NDC 69097-168-64, Rx Only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.
Package NDCs: 69097-168-48; 69097-168-87; 69097-168-64; 69097-168-32; 69097-168-53
Lack of Assurance of Sterility: environmental monitoring failure.CIPLA / 9041 cartonsClass IIOngoing
D-0019-202309-29-2022Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: ALPHAPHARM PTY LTD, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-027-10
Package NDCs: 60429-027-10; 60429-027-90; 60429-025-10; 60429-025-90; 60429-026-10; 60429-026-90
Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg TabletsGolden State Medical Supply Inc. / 2,584 BottlesClass IOngoing
D-0003-202309-27-2022Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. NDC 0409-5921-16 (vial) 0409-5921-01 (carton)
Package NDCs: 0409-5921-16; 0409-5921-01; 0409-5922-16; 0409-5922-01
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.Pfizer Inc. / 103,150 10 mL vialsClass IIOngoing
D-0013-202309-26-2022Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520; Made in India, NDC 55150-154-10.
Package NDCs: 55150-154-10; 55150-155-20
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.AuroMedics Pharma LLC / 89400 vialsClass IIOngoing
D-1551-202209-26-2022Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10
Package NDCs: 55150-188-10
Presence of Particulate Matter: Piece of metal found in a vialAuroMedics Pharma LLC / 88080 vialsClass IIIOngoing
D-1547-202209-21-2022Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
Package NDCs: 61748-015-30; 61748-015-11; 61748-018-30; 61748-018-60; 61748-018-01; 61748-018-11
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).Akorn, Inc. / 18,145 bottlesClass IIOngoing
D-1542-202209-21-2022Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2 g vials per carton NDC 67457-352-10, Rx only, Mylan Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 U.S.A
Package NDCs: 67457-353-25; 67457-353-10; 67457-350-50; 67457-350-10; 67457-351-01; 67457-351-10; 67457-352-02; 67457-352-10
Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.Viatris Inc / 3,931 cartonsClass IIOngoing
D-1548-202209-21-2022Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031.
Package NDCs: 61748-015-30; 61748-015-11; 61748-018-30; 61748-018-60; 61748-018-01; 61748-018-11
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).Akorn, Inc. / 177,439 bottlesClass IIOngoing
D-1544-202209-20-2022oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-07.Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).QuVa Pharma, Inc. / 1994 bagsClass IIIOngoing
D-1541-202209-19-2022Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC. East Brunswick, NJ 08816. NDC# 29300-137-01
Package NDCs: 29300-468-05; 29300-468-10; 29300-468-50; 29300-468-01; 29300-136-01; 29300-136-05; 29300-136-10; 29300-136-50; 29300-137-01; 29300-137-05; 29300-137-10; 29300-137-25; 29300-135-01; 29300-135-05; 29300-135-10; 29300-135-50
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,UNICHEM PHARMACEUTICALS USA INC / 18,960 bottles of 100Class IIIOngoing
D-1543-202209-16-2022Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.
Package NDCs: 0078-0246-61; 0078-0246-15; 0078-0248-61; 0078-0248-15; 0078-0274-22
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.Novartis Pharmaceuticals Corporation / 132,999 cartonsClass IIOngoing
D-1549-202209-16-2022Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
Package NDCs: 16110-080-45
Failed Viscosity specification: Slightly higher OOS results obtained for viscosityALMIRALL, LLC / 5,315 tubesClass IIIOngoing
D-1545-202209-15-2022Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86.
Package NDCs: 69097-318-86; 69097-318-87; 69097-318-32; 69097-318-53; 69097-319-86; 69097-319-87; 69097-319-32; 69097-319-53; 69097-321-86; 69097-321-87; 69097-321-32; 69097-321-53
Lack of Assurance of SterilityCIPLA / 641,160 ampulesClass IIOngoing
D-1538-202209-15-2022Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack Inc, Indiana PA. Original NDC# 68180-0980-03, Repackaged NDC# 70518-0468-00Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.RemedyRepack Inc. / 1,699 blister cards/30 tablets eachClass IITerminated
D-0001-202309-14-2022Sanitizing Hand Spray 80% (alcohol 80% v/v) Packaged in 2 FL OZ (60 mL) bottles, Salon Technologies International 8810 Commodity Circle STE 22-23, Orlando, FL 32819, UPC 6 96952 12904 5GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.Salon Technologies International Inc / 1656 bottlesClass IIOngoing
D-0002-202309-14-2022Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) packaged in 473 mL/16 fl. oz. bottles, Dist. By Antica Farmacista Seattle, WA 98122 UPC 8 47005 00450 9Chemical Contamination: product found to contain benzeneSalon Technologies International Inc / 512 bottlesClass IOngoing
D-0007-202309-14-2022Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16
Package NDCs: 43598-405-11; 43598-405-16
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.Dr. Reddy's Laboratories, Inc. / 2,838 ampulesClass IIIOngoing
D-1536-202209-13-2022Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03
Package NDCs: 68180-512-09; 68180-512-02; 68180-512-30; 68180-512-03; 68180-512-01; 68180-513-30; 68180-513-09; 68180-513-03; 68180-513-02; 68180-513-05; 68180-513-01; 68180-517-03; 68180-517-04; 68180-517-02; 68180-517-01; 68180-517-09; 68180-517-30; 68180-980-09; 68180-980-02; 68180-980-03; 68180-980-05; 68180-980-30; 68180-980-01; 68180-981-09; 68180-981-01; 68180-981-02; 68180-981-03; 68180-981-05; 68180-981-30; 68180-982-09; 68180-982-01; 68180-982-02; 68180-982-03; 68180-982-30; 68180-979-09; 68180-979-01; 68180-979-03; 68180-979-30
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.Lupin Pharmaceuticals Inc. / 11,802 1000-count bottlesClass IIOngoing
D-1535-202209-12-2022Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.
Package NDCs: 72189-330-80
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.Direct Rx / 20 tubesClass IIOngoing
D-0008-202309-09-2022Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53220 1Marketed Without An Approved NDA/ANDA; Unapproved new drugJustified Laboratories / UnknownClass IIOngoing
D-0009-202309-09-2022Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53221 8Marketed Without An Approved NDA/ANDA; Unapproved new drugJustified Laboratories / UnknownClass IIOngoing
D-1537-202209-01-2022Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially cause disease, For use when soap and water are not available, Alcohol 80% Topical Solution, Antiseptic, 8.5 oz./ 250 mL bottles, Made and Distributed by: Superior Glove Works Ltd., 36 Vimy Street, Acton, Ontario, L7J 1S1, Canada, Made in Canada, UPC: 779406201594.CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.SUPERIOR GLOVE WORKS, LTD. / 7,296 bottlesClass IIOngoing
D-1495-202208-31-2022Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
Package NDCs: 17478-711-10; 17478-711-30; 17478-711-31
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.Akorn, Inc. / 82,689 tubesClass IIOngoing
D-1496-202208-31-2022Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35
Package NDCs: 17478-622-35
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.Akorn, Inc. / 48,636 tubesClass IIOngoing
D-0006-202308-30-2022Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon Scent, 1250 mL (42 fl oz.), Manufactured for: Triple S, 800-323-2251, Made in USA, NDC 11429-1010-8
Package NDCs: 11429-1010-1; 11429-1010-7; 11429-1010-3; 11429-1010-8
Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.Woodbine Products Co Inc / 595 cases (4 bottles per case)Class IIIOngoing
D-1539-202208-29-2022Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, Rx Only, 100 tablets per bottle, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0555-0777-02.
Package NDCs: 0555-0971-02; 0555-0775-02; 0555-0972-02; 0555-0776-02; 0555-0777-02; 0555-0973-02; 0555-0974-02
Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.Teva Pharmaceuticals USA Inc / 83,703 bottlesClass IIOngoing
D-1526-202208-26-2022TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 16 vialsClass IIOngoing
D-1529-202208-26-2022TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 3 vialsClass IIOngoing
D-1527-202208-26-2022TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 7 vialsClass IIOngoing
D-1521-202208-26-2022Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 4 syringesClass IIOngoing
D-1523-202208-26-2022TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 3 vialsClass IIOngoing
D-1524-202208-26-2022TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 348 vialsClass IIOngoing
D-1525-202208-26-2022TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 1 vialClass IIOngoing
D-1533-202208-26-2022QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 1 vialClass IIOngoing
D-1519-202208-26-2022Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 24 syringesClass IIOngoing
D-1522-202208-26-2022TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 2 vialsClass IIOngoing
D-1530-202208-26-2022TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 11 vialsClass IIOngoing
D-1528-202208-26-2022TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 2 vialsClass IIOngoing
D-1534-202208-26-2022QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 1 vialClass IIOngoing
D-1516-202208-26-2022MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 3 vialsClass IIOngoing
D-1531-202208-26-2022TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 2 vialsClass IIOngoing
D-1520-202208-26-2022Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 4 syringesClass IIOngoing
D-1517-202208-26-2022MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 4 vialsClass IIOngoing
D-1518-202208-26-2022Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 8 syringesClass IIOngoing
D-1515-202208-26-2022L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 1 vialClass IIOngoing
D-1532-202208-26-2022TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityCarolina Infusion / 1 vialClass IIOngoing
D-1473-202208-23-2022Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01
Package NDCs: 0093-1177-01
CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.Teva Pharmaceuticals USA Inc / Class IIOngoing
D-1546-202208-23-2022ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01
Package NDCs: 69315-167-03; 69315-167-01; 69315-167-09; 69315-166-03; 69315-166-01; 69315-166-09; 69315-165-03; 69315-165-01
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsulesLeading Pharma, LLC / 960 bottles (100 capsules)Class IIIOngoing
D-1498-202208-22-2022Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.
Package NDCs: 76282-708-50
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.CIPLA / 3,468 bottlesClass IIOngoing
D-1499-202208-22-2022Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
Package NDCs: 69097-341-35
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.CIPLA / 117,844 bottlesClass IIOngoing
D-1540-202208-22-2022PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
Package NDCs: 0409-4699-50; 0409-4699-30; 0409-4699-53; 0409-4699-33; 0409-4699-54; 0409-4699-24; 0409-6010-02; 0409-6010-25
Presence of particulate matterPfizer Inc. / 5,390 vialsClass IOngoing
D-1497-202208-17-2022Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36.
Package NDCs: 45802-063-35; 45802-063-36; 45802-063-05; 45802-064-35; 45802-064-36; 45802-064-05; 45802-065-35
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.Padagis US LLC / 57,816 tubesClass IIOngoing
D-0016-202308-15-2022Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50.Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.Ultra Chem Labs Corp / 5-10 gallonsClass IIOngoing
D-0017-202308-15-2022Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle, and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50.Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.Ultra Chem Labs Corp / 5-10 gallonsClass IIOngoing
D-1346-202208-10-2022PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.Nephron Sterile Compounding Center LLC / 2030 bagsClass IIOngoing