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 August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0201-2023 | 12-22-2022 | DEXAMETHASONE 16MG/ML (3ML VIAL) INJECTABLE; DEXAMETHASONE 24MG/ML INJECTABLE; DEXAMETHASONE-PF- 0.1% (1ML DROPPER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0230-2023 | 12-22-2022 | PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID (10ML VIAL) 50MG/50MG/ML (5%/5%) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0186-2023 | 12-22-2022 | Chlorpheniramine/Hyoscyamine (1ML) 10MG/0.25MG/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0207-2023 | 12-22-2022 | Ethyl Alcohol 95% (5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0210-2023 | 12-22-2022 | GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 200MG/ML (1ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 220MG/ML (30ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (1ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (2ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED-PF- 200MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0220-2023 | 12-22-2022 | METHION/INOSIT/CHOLINE/CYANOCOBAL 25MG/50MG/50MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/METHYLCOBAL 15MG/50MG/100MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/RIBOFLA/NIACINAMIDE/PYRIDOX/ASCORBIC ACID 15.625MG/31.25MG/31.25MG/6.25MG/62.5MG/6.25MG/62.5MG/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0219-2023 | 12-22-2022 | MAGNESIUM CHLORIDE HEXAHYDRATE-PF- 200MG/ML (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0197-2023 | 12-22-2022 | Ceftazidime Intravitreal (1ML vial) 22.5 MG/ML(2.25MG/0.1ML) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0189-2023 | 12-22-2022 | Minoxidil 0.75% (1.5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0228-2023 | 12-22-2022 | PE1/PAPAV/PHEN 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 30MCG/30MCG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 5.88MCG/17.65MG/0.588MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT (1ML) 10MCG/30MG/2MG/ML INJECTABLE PE1/PAPAV/PHENT 10MCG/18MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 10MCG/30MG/0.5MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 10MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 10MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 11.8MCG/18MG/0.6MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 12.2MCG/19.29MG/1.22MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 12.5MCG/24MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 20MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 20MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 30MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 30MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 30MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 40MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.88MCG/17.65MG/0.588MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.88MCG/18MG/0.6MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.8MCG/17.44MG/0.64MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.9MCG/17.64MG/0.59MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 50MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 50MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5MCG/15MG/0.5MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 60MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 60MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 70MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 8.3MCG/25MG/0.83MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 80MCG/30MG/3MG (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 10MCG/12MG/1MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 10MCG/30MG/2MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 20MCG/30MG/2MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 20MCG/30MG/4MG/0.4MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 30MCG/30MG/1MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 30MCG/30MG/2MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 40MCG/30MG/4MG/0.4MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 50MCG/30MG/2MG/0.1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 60MCG/30MG/4MG/0.15MG/ML (1ML VIAL) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0243-2023 | 12-22-2022 | VORICONAZOLE 10MG/ML (10ML DROPPER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0091-2023 | 12-22-2022 | Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15 Package NDCs: 50268-363-11; 50268-363-15 | Failed impurities/degradation specifications: Out of specification for unknown impurities. | AVKARE LLC / 1237 cartons | Class II | Completed |
| D-0184-2023 | 12-22-2022 | Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0409-3515-01 Package NDCs: 0409-6531-12; 0409-6531-02; 0409-6533-11; 0409-6533-01; 0409-6533-21; 0409-4332-11; 0409-4332-01; 0409-3515-11; 0409-3515-01 | Presence of Particulate Matter: Glass particulate matter detected in injectable. | Pfizer Inc. / 89,700 vials | Class I | Terminated |
| D-0231-2023 | 12-22-2022 | POLIDOCANOL 50MG/ML (5%) (30ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0215-2023 | 12-22-2022 | HYDROXOCOBALAMIN-PF- 1MG/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0204-2023 | 12-22-2022 | EDETATE DISODIUM (VET) 1% (3ML droptainer) OPH Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0211-2023 | 12-22-2022 | GLYCERIN 72% (W/V) (15ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0196-2023 | 12-22-2022 | Buprenorphine HCL 0.9 MG/ML (25ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0205-2023 | 12-22-2022 | Estradiol 0.05% OPH Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0223-2023 | 12-22-2022 | MITOMYCIN 0.2MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.2MG/ML (1ML VIAL) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0221-2023 | 12-22-2022 | METHOTREXATE INTRAVITREAL (1ML VIAL) 4MG/ML (400MCG/0.1ML) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0213-2023 | 12-22-2022 | GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 31%(V/V)/0.17%/0.00017% (10ML VIALS); GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 48.7%(W/V)/0.67%/0.00067% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0185-2023 | 12-22-2022 | Dutasteride 0.1% (1.5ML VIAL) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0224-2023 | 12-22-2022 | MITOMYCIN 0.4MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.4MG/ML (1ML VIAL) OPH SOLUTION; MITOMYCIN 0.4MG/ML (4ML VIAL) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0193-2023 | 12-22-2022 | Apomorphine HCL 2MG/ML (10ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0198-2023 | 12-22-2022 | Cholecalciferol (Vitamin D3) 100,000U/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0236-2023 | 12-22-2022 | SEMAGLUTIDE 0.5MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 1MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 2MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 4MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 5.4MG/ML (0.5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0195-2023 | 12-22-2022 | BSS Plus/Lidocaine Opth 1% (1ML syringe) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0130-2023 | 12-22-2022 | Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded by Pine Pharmaceuticals, 355 Riverwalk Pkwy, Tonawanda, NY 14150. NDC 69194-0948-1 | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Pine Pharmaceuticals, LLC / 11,453 vials | Class II | Terminated |
| D-0216-2023 | 12-22-2022 | KETAMINE 50MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0233-2023 | 12-22-2022 | PROGESTERONE-GS OIL- 100MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0202-2023 | 12-22-2022 | Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML (1ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0093-2023 | 12-21-2022 | Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg for: Apotex Corp. Weston, FL 33326, NDC 60505-1005-4 | Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life. | Apotex Corp. / 22,027 bottles | Class III | Terminated |
| D-0165-2023 | 12-20-2022 | Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-586-01 (Individual Dose NDC: 60687-586-11) Package NDCs: 60687-586-11; 60687-586-01; 60687-575-11; 60687-575-21 | Failed Impurities/Degradations Specifications | Amerisource Health Services LLC / 3,091 cartons | Class II | Terminated |
| D-0098-2023 | 12-20-2022 | Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00. | Failed Impurities/Degradation specifications | RemedyRepack Inc. / 132 Cards of 30 = 3960 Tablets | Class II | Terminated |
| D-0179-2023 | 12-19-2022 | Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901. Product Code EP130 | Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product | Spectrum Laboratory Products, Inc. / 1 bottle | Class I | Terminated |
| D-0180-2023 | 12-19-2022 | Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)1 G, (c) 25 G, (d) 5 G; Rx only. Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901. | Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product | Spectrum Laboratory Products, Inc. / 7 x 100G; 17 x 1G; 6 x 25G; 20 x 5G | Class I | Terminated |
| D-0090-2023 | 12-16-2022 | Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Distributed by Hikma Berkeley Heights, NJ 07922, NDC 0143-9299-01 Package NDCs: 0143-9299-01; 0143-9299-10 | Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg. | Hikma Pharmaceuticals USA Inc. / 13,760 vials | Class II | Terminated |
| D-0087-2023 | 12-16-2022 | Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01 Package NDCs: 13107-014-01; 13107-015-01 | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC / 7344 bottles | Class II | Ongoing |
| D-0257-2023 | 12-15-2022 | Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00048 6; b) 16 fl. oz. (473 mL) UPC 8 91857 00047 9, Manufactured by: Frenda Corporation Trujillo Alto, PR 00976 | cGMP Deviations | Frenda Corporation / 65,376 bottles | Class II | Terminated |
| D-0254-2023 | 12-15-2022 | Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (128 Fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00050 9 | cGMP Deviations | Frenda Corporation / 144 bottles | Class II | Terminated |
| D-0258-2023 | 12-15-2022 | Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00045 5; b) 16 fl. oz. (473 mL) UPC 8 91857 00055 4; c) Rubbing Alcohol 10 fl. oz. (296 mL) UPC 8 91857 00044 8, Manufactured by Frenda Corporation Trujillo Alto, PR 00976 | cGMP Deviations | Frenda Corporation / 44,140 bottles | Class II | Terminated |
| D-0255-2023 | 12-15-2022 | Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL. OZ. (946 mL.), Manufactured by: Frenda Corporation Trujilio Alto, PR 00976, UPC 8 91857 00052 3 | cGMP Deviations | Frenda Corporation / 8475 bottles | Class II | Terminated |
| D-0260-2023 | 12-15-2022 | Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 mL) UPC 8 70373 01323 1; b) 16 FL OZ (473 mL) UPC 8 70373 01332 3; c) 1 Gallon (128 FL OZ) 3785.41 mL UPC 8 70373 01330 4, Dist. By Target Price, Inc. Catano, PR | cGMP Deviations | Frenda Corporation / 12,130 bottles | Class II | Terminated |
| D-0256-2023 | 12-15-2022 | Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00054 7 | cGMP Deviations | Frenda Corporation / 164 bottles | Class II | Terminated |
| D-0259-2023 | 12-15-2022 | Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gallon (128 FL OZ) 3785.41 mL, Dist. by Target Price, Inc. Catano, PR, UPC 8 70373 01326 2 | cGMP Deviations | Frenda Corporation / 124 bottles | Class II | Terminated |
| D-0081-2023 | 12-12-2022 | Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01. | cGMP Deviations | Atlantic Management Resources Ltd. / 461 bottles | Class II | Terminated |
| D-0082-2023 | 12-12-2022 | Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01. | cGMP Deviations | Atlantic Management Resources Ltd. / 51 bottles | Class II | Terminated |
| D-0083-2023 | 12-12-2022 | ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc. (International), Mfg. by Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-712-01. | cGMP Deviations | Atlantic Management Resources Ltd. / 72 bottles | Class II | Terminated |
| D-0084-2023 | 12-12-2022 | Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-711-01. | cGMP Deviations | Atlantic Management Resources Ltd. / 26 bottles | Class II | Terminated |
| D-0100-2023 | 12-12-2022 | Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India. NDC 68180-659-06 Package NDCs: 68180-658-06; 68180-658-01; 68180-659-06; 68180-659-07; 68180-659-01 | Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study. | Lupin Pharmaceuticals Inc. / 16,056 30 count bottles | Class II | Terminated |
| D-0092-2023 | 12-09-2022 | Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-02, and b) 55 gallon bottle (208,198 ml), NDC 55533-524-03, Manufactured for: Multi-Mist Products A Division of NCH Corporation 1618 Northgate, Irving, Texas 75062 | CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits. | NCH Life Sciences LLC / 10,930 gallons | Class II | Completed |
| D-0267-2023 | 12-08-2022 | Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 30 mL Sterile Multiple Use Vial, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704. | Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy. | McGuff Compounding Pharmacy Services, Inc. / 255 vials | Class II | Terminated |
| D-0266-2023 | 12-08-2022 | Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 2 mL Sterile Single Use Vial, Preservative-Free, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704. | Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy. | McGuff Compounding Pharmacy Services, Inc. / 11 vials | Class II | Terminated |
| D-0088-2023 | 12-07-2022 | Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09 Package NDCs: 68180-556-09; 68180-557-09; 68180-557-03; 68180-558-09; 68180-558-03; 68180-554-09; 68180-554-03; 68180-559-03; 68180-559-09 | CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. | Lupin Pharmaceuticals Inc. / 30,612 bottles | Class II | Terminated |
| D-0089-2023 | 12-07-2022 | Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09 Package NDCs: 68180-556-09; 68180-557-09; 68180-557-03; 68180-558-09; 68180-558-03; 68180-554-09; 68180-554-03; 68180-559-03; 68180-559-09 | CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. | Lupin Pharmaceuticals Inc. / 23,736 | Class II | Terminated |
| D-0183-2023 | 12-06-2022 | Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Pfizer, Madison, NJ 07940, UPC 3 0573 1769 13 5 | Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back | Glaxosmithkline Consumer Healthcare Holdings DBA Haleon / 209,292 capsules | Class I | Terminated |
| D-0182-2023 | 12-06-2022 | Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Distributed by: Pfizer, Madison, NJ 07940, UPC 3 0573 0169 49 3 | Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back | Glaxosmithkline Consumer Healthcare Holdings DBA Haleon / 88,380 capsules | Class I | Terminated |
| D-0181-2023 | 12-06-2022 | Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 0573 0154 60 4), and b) 200-count bottles (UPC 3 0573 0154 21 5), Pfizer, Madison, NJ 07940 | Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back | Glaxosmithkline Consumer Healthcare Holdings DBA Haleon / 321,246 tablets | Class I | Terminated |
| D-0094-2023 | 12-06-2022 | Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured By: HETERO LABS LIMITED, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-627-26 Package NDCs: 31722-627-26; 31722-627-46 | Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content | Camber Pharmaceuticals, Inc / N/A | Class III | Terminated |
| D-0077-2023 | 12-05-2022 | Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816; Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC #: 70518-3493-00. | Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency. | RemedyRepack Inc. / 9 boxes | Class II | Terminated |
| D-0077-2024 | 12-02-2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-03, UPC 3-0766-0746-70-6 | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC / N/A | Class II | Completed |
| D-0078-2024 | 12-02-2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-05, UPC 3-0766-3072-14-7 | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC / N/A | Class II | Completed |
| D-0076-2024 | 12-02-2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 72-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-02, UPC 3-0766-0746-50-8 | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC / N/A | Class II | Completed |
| D-0074-2024 | 12-02-2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-01, UPC 3-0766-0746-80-5 Package NDCs: 0135-0118-01; 0135-0118-04; 0135-0118-14; 0135-0118-83; 0135-0180-01; 0135-0180-02; 0135-0180-14; 0135-0181-01; 0135-0181-02; 0135-0181-03; 0135-0181-05; 0135-0181-06; 0135-0181-07; 0135-0181-14; 0135-0228-01; 0135-0228-04; 0135-0228-05; 0135-0228-06; 0135-0228-07; 0135-0540-01; 0766-0746-80 | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC / N/A | Class II | Completed |
| D-0073-2024 | 12-02-2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-06, UPC 3-0766-0745-85-3 Package NDCs: 0135-0118-01; 0135-0118-04; 0135-0118-14; 0135-0118-83; 0135-0180-01; 0135-0180-02; 0135-0180-14; 0135-0181-01; 0135-0181-02; 0135-0181-03; 0135-0181-05; 0135-0181-06; 0135-0181-07; 0135-0181-14; 0135-0228-01; 0135-0228-04; 0135-0228-05; 0135-0228-06; 0135-0228-07; 0135-0540-01; 0766-0745-85 | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC / N/A | Class II | Completed |
| D-0079-2024 | 12-02-2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-83, UPC 3-0766-0746-50-8 Package NDCs: 0135-0118-01; 0135-0118-04; 0135-0118-14; 0135-0118-83; 0135-0180-01; 0135-0180-02; 0135-0180-14; 0135-0181-01; 0135-0181-02; 0135-0181-03; 0135-0181-05; 0135-0181-06; 0135-0181-07; 0135-0181-14; 0135-0228-01; 0135-0228-04; 0135-0228-05; 0135-0228-06; 0135-0228-07; 0135-0540-01; 0766-0746-50 | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC / N/A | Class II | Completed |
| D-0075-2024 | 12-02-2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-14, UPC 3-0766-0746-10-2 Package NDCs: 0135-0118-01; 0135-0118-04; 0135-0118-14; 0135-0118-83; 0135-0180-01; 0135-0180-02; 0135-0180-14; 0135-0181-01; 0135-0181-02; 0135-0181-03; 0135-0181-05; 0135-0181-06; 0135-0181-07; 0135-0181-14; 0135-0228-01; 0135-0228-04; 0135-0228-05; 0135-0228-06; 0135-0228-07; 0135-0540-01; 0766-0746-10 | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC / N/A | Class II | Completed |
| D-0086-2023 | 12-01-2022 | Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 300 mg of organically bound iodine, 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium, For Injection or oral use; Rx Only, BayCare Central Pharmacy, 7802 Telecom Parkway, Temple Terrace, FL 33637. | Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL | BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy / 250 syringes | Class I | Terminated |
| D-0085-2023 | 12-01-2022 | Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. Package NDCs: 62756-183-83; 62756-183-88; 62756-183-08; 62756-183-13; 62756-183-18; 62756-184-83; 62756-184-88; 62756-184-08; 62756-184-13; 62756-184-18; 62756-185-83; 62756-185-88; 62756-185-08; 62756-185-13; 62756-185-18 | Presence of foreign substance | SUN PHARMACEUTICAL INDUSTRIES INC / Lot HAC1474A: 4296 Bottles, Lot HAC1474B: 145 Bottles, Lot HAC1503A: 2124 Bottles | Class II | Terminated |
| D-0131-2023 | 11-29-2022 | Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05 | Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial | Accord Healthcare, Inc. / Unknown | Class I | Terminated |
| D-0078-2023 | 11-29-2022 | FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01 | Underfilled units. | OurPharma LLC / 691 cassettes | Class II | Terminated |
| D-0080-2023 | 11-28-2022 | 8.4% 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. | Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration. | Exela Pharma Sciences LLC / 37,320 vials | Class I | Terminated |
| D-0079-2023 | 11-28-2022 | 8.4% 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 administration. | Exela Pharma Sciences LLC / 489,600 vials | Class I | Terminated |
| D-0076-2023 | 11-25-2022 | 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Package NDCs: 0264-5802-00; 0264-5802-10; 0264-5804-00; 0061832446 | Lack of sterility assurance: Bags have the potential to leak. | B. Braun Medical, Inc. / 756 bags | Class II | Terminated |
| D-0072-2023 | 11-23-2022 | Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816, NDC 23155-490-01 Package NDCs: 23155-489-01; 23155-489-05; 23155-490-01; 23155-490-05 | Subpotent Drug | Heritage Pharmaceuticals Inc / 13805 Bottles each containing 100 tablets | Class II | Terminated |
| D-0075-2023 | 11-22-2022 | 0.9% 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. / 4,097 cases/12 bags per case | Class II | Ongoing |
| D-0127-2023 | 11-22-2022 | Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-461-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047. Package NDCs: 63323-472-03; 63323-472-17; 63323-472-01; 63323-472-37; 63323-463-01; 63323-463-57; 63323-461-01; 63323-461-57; 63323-468-02; 63323-468-37; 63323-468-01; 63323-468-17 | Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. | Fresenius Kabi USA, LLC / 40,375 vials | Class II | Terminated |
| D-0129-2023 | 11-22-2022 | Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), Rx only, Fresenius Kabi, Lake Zurich, IL 60047. Package NDCs: 63323-472-03; 63323-472-17; 63323-472-01; 63323-472-37; 63323-463-01; 63323-463-57; 63323-461-01; 63323-461-57; 63323-468-02; 63323-468-37; 63323-468-01; 63323-468-17 | Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. | Fresenius Kabi USA, LLC / 31,600 vials | Class II | Terminated |
| D-0128-2023 | 11-22-2022 | Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-463-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-463-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047. Package NDCs: 63323-472-03; 63323-472-17; 63323-472-01; 63323-472-37; 63323-463-01; 63323-463-57; 63323-461-01; 63323-461-57; 63323-468-02; 63323-468-37; 63323-468-01; 63323-468-17 | Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. | Fresenius Kabi USA, LLC / 40,025 vials | Class II | Terminated |
| D-0073-2023 | 11-21-2022 | Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Tablets USP, packaged as (a) 20 count carton NDC 49032-273-20; (b) 30 count carton, NDC49032-273-30; Distributed by: Walmart Inc., Bentonville, AR 72716, Product of India | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / 25,176, 30-count; 22,968 20-count | Class III | Terminated |
| D-0071-2023 | 11-16-2022 | Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches. | Noven Pharmaceuticals Inc / 3977 boxes | Class II | Ongoing |
| D-0070-2023 | 11-14-2022 | Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 Package NDCs: 42192-614-10; 42192-614-30; 42192-614-05 | Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode. | Acella Pharmaceuticals, LLC / 637 cartons | Class III | Terminated |
| D-0069-2023 | 11-14-2022 | Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 Package NDCs: 42192-614-10; 42192-614-30; 42192-614-02 | Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode. | Acella Pharmaceuticals, LLC / 574 cartons | Class III | Terminated |
| D-0074-2023 | 11-14-2022 | Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 300025, NDC 42192-113-60 | Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period. | Acella Pharmaceuticals, LLC / 528 cartons | Class III | Terminated |
| D-0065-2023 | 11-10-2022 | PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2. | CGMP Deviations: Potential for cross contamination due to product carry over. | Nephron Sterile Compounding Center LLC / 56,220 vials | Class II | Terminated |
| D-0064-2023 | 11-10-2022 | PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6. | CGMP Deviations: Potential for cross contamination due to product carry over. | Nephron Sterile Compounding Center LLC / 34,020 vials | Class II | Terminated |
| D-0061-2023 | 11-10-2022 | Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Forumulations Private Limited,9/215, Pudupakkam, Kelambakkam - 603 103. NDC 49884-038-01 | Failed Impurities/Degradation Specifications | Par Formulations Private Limited / 218 bottles/100 capsules per bottle | Class II | Terminated |
| D-0062-2023 | 11-09-2022 | 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37 Package NDCs: 0990-7730-36; 0990-7730-37; 0990-7983-61; 0990-7983-02; 0990-7983-03; 0990-7983-09; 0990-7983-55; 0990-7983-53; 0990-7984-37; 0990-7984-20; 0990-7984-13; 0990-7984-23; 0990-7984-36; 0990-7985-02; 0990-7985-03; 0990-7985-09 | Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility. | ICU Medical Inc / 137,120 bags | Class II | Ongoing |
| D-0161-2023 | 11-09-2022 | Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 100 Count bottle: 0527-1632-01; NDC 1,000 bottle: 0527-1632-10 | Failed Impurity/Degradation Specifications | Lannett Company Inc. / 20,040 bottles | Class III | Terminated |
| D-0261-2023 | 11-09-2022 | Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Contagiosum, Topical Cream, Net weight 0.78 oz (22g) tube, UPC 8 60322 00180 8, Manufactured by: Dr. Retter EC Warszawska 17, 05-075 Warszawa Poland | CGMP deviations | DISCOVERY PHARMA LLC / 21,892 tubes | Class II | Terminated |
| D-0060-2023 | 11-09-2022 | Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ. | Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost. | ImprimisRx NJ / 960 bottles | Class II | Terminated |
| D-0160-2023 | 11-09-2022 | Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-1632-10 | Failed Impurity/Degradation Specifications | Lannett Company Inc. / 5,640 bottles | Class III | Terminated |
| D-0066-2023 | 11-05-2022 | Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz. (3,785 ml.) jug, NDC 74943-125-28, Manufactured by B&B Blending, LLC, Northglenn, CO. | Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol. | Adam's Polishes LLC / 3,441 gallons total | Class I | Ongoing |
| D-0067-2023 | 11-05-2022 | Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz. (3,785 ml.) jug, NDC 74943-125-28, Manufactured by B&B Blending, LLC, Northglenn, CO. | CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol. | Adam's Polishes LLC / 3,441 gallons total | Class II | Ongoing |
| D-0101-2023 | 11-02-2022 | Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05 | cGMP deviation: discontinue of stability support for product. | Direct Rx / 11 bottles | Class II | Terminated |
| D-0063-2023 | 10-21-2022 | Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05 | Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness. | Viatris Inc / 2,794 bottles | Class II | Terminated |
| D-0025-2023 | 10-18-2022 | Susvimo (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 implants | Class III | Terminated |
| D-0024-2023 | 10-18-2022 | Buprenorphine 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 Substance | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Terminated |
| D-0059-2023 | 10-13-2022 | Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA. Package NDCs: 80803-153-50 | Failed Stability Specifications | Aadi Bioscience / 2,333 vials | Class III | Terminated |
