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 February 23, 2024 and include a total of 16029 recall reports.

Recall Number Recall Initiation Date Product Description Recall Reason Recall Firm / Quantity Recall Classification Status
D-0304-202411-13-2023LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-5Non-SterilityKilitch Healthcare India Limited / 6,024 bottlesClass IOngoing
D-0303-202411-13-2023EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10 mL) bottles, Distributed by: Walmart Inc., Bentonville, AR 72712, NDC 79903-168-01Non-SterilityKilitch Healthcare India Limited / 33,984 bottlesClass IOngoing
D-0292-202411-13-2023CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (NDC 76168-714-10) and b) 0.33 FL OZ (10 mL) bottles (Twin pack) (NDC 76168-714-20), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.Non-SterilityKilitch Healthcare India Limited / 137,784 bottlesClass IOngoing
D-0291-202411-13-2023Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017Non-SterilityKilitch Healthcare India Limited / 210,192 bottlesClass IOngoing
D-0307-202411-13-2023Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-3Non-SterilityKilitch Healthcare India Limited / 7,776 bottlesClass IOngoing
D-0293-202411-13-2023Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94Non-SterilityKilitch Healthcare India Limited / 1,492,344 bottlesClass IOngoing
D-0130-202411-10-2023PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 60429-737-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Package NDCs: 60429-734-30; 60429-734-90; 60429-734-10; 60429-735-30; 60429-735-90; 60429-735-10; 60429-736-30; 60429-736-90; 60429-736-10; 60429-737-30; 60429-737-90; 60429-737-10
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of ParoxetineGolden State Medical Supply Inc. / 5626 bottlesClass IIOngoing
D-0129-202411-10-2023PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Package NDCs: 60429-734-30; 60429-734-90; 60429-734-10; 60429-735-30; 60429-735-90; 60429-735-10; 60429-736-30; 60429-736-90; 60429-736-10; 60429-737-30; 60429-737-90; 60429-737-10
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of ParoxetineGolden State Medical Supply Inc. / 2502 bottlesClass IIOngoing
D-0127-202411-10-2023Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30
Package NDCs: 0591-2924-18; 0591-2925-32; 0591-2925-30; 0591-2926-25; 0591-2926-30
OOS for viscosityTeva Pharmaceuticals USA, Inc / Class IIIOngoing
D-0125-202411-10-2023Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Use Only, Not for IV Use, This is a Compounded Drug, Hospital & Office Use Only, Fagron Sterile Services, 8710 E 34th St N Wichita, KS 67226. NDC 71266-8240-01Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropperFagron Compounding Services / 756 bottlesClass IIIOngoing
D-0128-202411-10-2023PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 60429-734-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Package NDCs: 60429-734-30; 60429-734-90; 60429-734-10; 60429-735-30; 60429-735-90; 60429-735-10; 60429-736-30; 60429-736-90; 60429-736-10; 60429-737-30; 60429-737-90; 60429-737-10
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of ParoxetineGolden State Medical Supply Inc. / 1941 bottlesClass IIOngoing
D-0106-202411-09-2023Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supply, 2011 W Cumberland St. Dunn, NC 28334.cGMP DeviationsFamily Medical Supply Inc / 26,657 CylindersClass IIOngoing
D-0140-202411-09-2023LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, Carie Boyd Pharmaceuticals, 8400 Esters Blvd, Ste# 190, Irving, TX 75063, NDC73271-1003-1Product Mix-up: Incorrect Product FormulationRight Value Drug Stores, LLC dba Carie Boyd's Prescription Shop / 190 syringesClass IIIOngoing
D-0138-202411-08-2023Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893 92767 8), b) 120 count (UPC 1 95893 54697 8), c) 180 count (UPC 1 95893 99957 6) bottles, Manufactured for SUGARMDS LLC, Port St. Lucie, FL 34952.MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburideSUGARMDS LLC / 32,117Class IOngoing
D-0124-202411-07-2023Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-188-01.
Package NDCs: 68462-188-01; 68462-188-05; 68462-189-01; 68462-189-05; 68462-190-30; 68462-190-50; 68462-190-01; 68462-190-05; 68462-178-01; 68462-178-05; 68462-179-01; 68462-179-05
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as NaproxenGlenmark Pharmaceuticals Inc., USA / Class IIOngoing
D-0123-202411-07-2023Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-406-01
Package NDCs: 68462-406-01; 68462-406-10; 68462-302-01; 68462-302-05
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as NaproxenGlenmark Pharmaceuticals Inc., USA / 37,200 bottlesClass IIOngoing
D-0145-202411-06-2023VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01
Package NDCs: 50419-390-01; 50419-391-01; 50419-392-01; 50419-393-02; 50419-393-03
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testingBayer Healthcare Pharmaceuticals Inc. / 192 bottlesClass IOngoing
D-0089-202411-06-2023Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1
Package NDCs: 51672-3007-1
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.Taro Pharmaceuticals Inc. / 11,196 bottlesClass IIIOngoing
D-0121-202411-01-2023Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Package NDCs: 60505-0097-1; 60505-0097-9; 60505-0097-2; 60505-0097-4; 60505-0097-7; 60505-0097-5; 60505-0083-1; 60505-0083-9; 60505-0083-2; 60505-0083-4; 60505-0083-0; 60505-0083-5; 60505-0084-1; 60505-0084-9; 60505-0084-2; 60505-0084-4; 60505-0084-5; 60505-0101-1; 60505-0101-9; 60505-0101-2; 60505-0101-4; 60505-0101-5; 60505-0101-7
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of ParoxetineApotex Corp. / 25,776Class IIOngoing
D-0139-202411-01-2023Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun-248 197 Uttarakhand, India Distributed By: Padagis, Allegan, MI 49010. NDC: 0574-0118-30
Package NDCs: 0574-0118-30
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsulesPadagis US LLC / 7,032 bottlesClass IIOngoing
D-0122-202411-01-2023Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Package NDCs: 60505-0097-1; 60505-0097-9; 60505-0097-2; 60505-0097-4; 60505-0097-7; 60505-0097-5; 60505-0083-1; 60505-0083-9; 60505-0083-2; 60505-0083-4; 60505-0083-0; 60505-0083-5; 60505-0084-1; 60505-0084-9; 60505-0084-2; 60505-0084-4; 60505-0084-5; 60505-0101-1; 60505-0101-9; 60505-0101-2; 60505-0101-4; 60505-0101-5; 60505-0101-7
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of ParoxetineApotex Corp. / 4,074Class IIOngoing
D-0120-202411-01-2023Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Package NDCs: 60505-0097-1; 60505-0097-9; 60505-0097-2; 60505-0097-4; 60505-0097-7; 60505-0097-5; 60505-0083-1; 60505-0083-9; 60505-0083-2; 60505-0083-4; 60505-0083-0; 60505-0083-5; 60505-0084-1; 60505-0084-9; 60505-0084-2; 60505-0084-4; 60505-0084-5; 60505-0101-1; 60505-0101-9; 60505-0101-2; 60505-0101-4; 60505-0101-5; 60505-0101-7
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of ParoxetineApotex Corp. / 48,623Class IIOngoing
D-0119-202411-01-2023Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Package NDCs: 60505-0097-1; 60505-0097-9; 60505-0097-2; 60505-0097-4; 60505-0097-7; 60505-0097-5; 60505-0083-1; 60505-0083-9; 60505-0083-2; 60505-0083-4; 60505-0083-0; 60505-0083-5; 60505-0084-1; 60505-0084-9; 60505-0084-2; 60505-0084-4; 60505-0084-5; 60505-0101-1; 60505-0101-9; 60505-0101-2; 60505-0101-4; 60505-0101-5; 60505-0101-7
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of ParoxetineApotex Corp. / 34,392Class IIOngoing
D-0131-202410-31-2023LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0087-1Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.Cardinal Health Inc. / 11629 unitsClass IOngoing
D-0133-202410-31-2023LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0090-1Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.Cardinal Health Inc. / 119,871 bottlesClass IOngoing
D-0136-202410-31-2023LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0587-1Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.Cardinal Health Inc. / 8,784 bottlesClass IOngoing
D-0135-202410-31-2023LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0088-1Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.Cardinal Health Inc. / 11,782 bottlesClass IOngoing
D-0134-202410-31-2023LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC:70000-0090-2 (Carton); 70000-0090-1 (Bottle)Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.Cardinal Health Inc. / 28477 cartonsClass IOngoing
D-0107-202410-31-2023Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 1,271,810 bottlesClass IOngoing
D-0132-202410-31-2023LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio. 43017, Made in India NDC: 70000-0089-1Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.Cardinal Health Inc. / 21,802 bottlesClass IOngoing
D-0108-202410-31-2023Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 65,880 bottlesClass IOngoing
D-0099-202410-30-2023V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd., Melbourne, FL 32935Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).Grato Holdings, Inc. / 1,333 30mL bottlesClass IIICompleted
D-0114-202410-27-2023Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By Lupin, PKG by Vangard Glasgow, KY 42141.
Package NDCs: 0615-7689-39; 0615-7689-31; 0615-7689-05; 0615-7718-39; 0615-7718-31; 0615-7718-05; 0615-7714-39; 0615-7714-30; 0615-7714-05; 0615-8252-39; 0615-8252-05; 0615-8253-39; 0615-8253-05; 0615-8253-30; 0615-8254-05; 0615-8254-39; 0615-8254-30; 0615-8255-39; 0615-8255-05; 0615-8255-30; 0615-8256-39; 0615-8256-05
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lotsNCS Healthcare of Kentucky Inc / 12 cardsClass IIIOngoing
D-0113-202410-27-2023Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141.
Package NDCs: 0615-7689-39; 0615-7689-31; 0615-7689-05; 0615-7718-39; 0615-7718-31; 0615-7718-05; 0615-7714-39; 0615-7714-30; 0615-7714-05
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lotsNCS Healthcare of Kentucky Inc / 1,344 cardsClass IIIOngoing
D-0093-202410-26-2023Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08.
Package NDCs: 66689-307-08
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.VistaPharm LLC / 11,633 bottlesClass IIIOngoing
D-0153-202410-23-2023Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152
Package NDCs: 0904-7079-24; 0904-7079-57
Failed Content Uniformity SpecificationsThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 3718 saleable unitsClass IOngoing
D-0112-202410-23-2023Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India,
Package NDCs: 68462-390-30; 68462-390-90; 68462-390-10; 68462-391-30; 68462-391-90; 68462-391-10
Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).Glenmark Pharmaceuticals Inc., USA / 8,448 30-count bottles, 168 1000-count bottlesClass IIIOngoing
D-0092-202410-23-2023Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.
Package NDCs: 68462-319-60; 68462-319-05; 68462-320-60; 68462-320-05
Failed Dissolution Specifications: Out of specification for dissolution.Glenmark Pharmaceuticals Inc., USA / 16,944 bottlesClass IIOngoing
D-0225-202410-20-2023Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalupe, Zapopan Jal Mexico, UPC 7 502214 014598Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.Botanical Be / Class IOngoing
D-0085-202410-20-2023Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01
Package NDCs: 68462-878-30; 68462-878-01; 68462-878-05; 68462-879-30; 68462-879-01; 68462-879-05; 68462-880-30; 68462-880-01; 68462-880-05
Failed Impurities/Degradation SpecificationsGlenmark Pharmaceuticals Inc., USA / 480 100-count bottlesClass IIIOngoing
D-0224-202410-20-2023Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de Mexico, Melchol Ocampo # 65 Local D, Delegacion Xochimilco CP 16800, Mexico DF, UPC 7 501031 111138Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.Botanical Be / 235 bottlesClass IOngoing
D-0226-202410-20-2023Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.Botanical Be / 300 bottlesClass IOngoing
D-0095-202410-20-2023Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30
Package NDCs: 68462-494-30; 68462-494-90; 68462-495-30; 68462-495-90; 68462-496-30; 68462-496-90
Failed Dissolution SpecificationsGlenmark Pharmaceuticals Inc., USA / 5,856 bottlesClass IIOngoing
D-0115-202410-20-2023Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for ITF Pharma, Inc., Berwyn, PA 19312 USA NDC:70726-0303-1 (carton) and 70726-0303-2 (bottle)
Package NDCs: 70726-0303-2; 70726-0303-1
Failed Viscosity Specifications: Out-of-specification test results for viscosityITF PHARMA INC / 1,792 bottlesClass IIOngoing
D-0103-202410-20-2023DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118 ml) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00027 4Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.Omega & Delta Co., Inc. / 48,145 4 oz bottlesClass IIOngoing
D-0083-202410-20-2023Liothyronine Sodium Tablets, USP, 5 mcg, 100-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 62756-589-88
Package NDCs: 62756-589-83; 62756-589-01; 62756-589-88; 62756-589-08; 62756-589-18; 62756-590-83; 62756-590-01; 62756-590-88; 62756-590-08; 62756-590-18; 62756-591-83; 62756-591-01; 62756-591-88; 62756-591-08; 62756-591-18
Failed Impurities/Degradation Specifications.SUN PHARMACEUTICAL INDUSTRIES INC / 7392 BottlesClass IIOngoing
D-0105-202410-20-2023Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.Omega & Delta Co., Inc. / 4,848 7.5 oz bottlesClass IIOngoing
D-0104-202410-20-2023DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00030 4Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.Omega & Delta Co., Inc. / 23,136 8 OZ bottlesClass IIOngoing
D-0094-202410-20-2023Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11
Package NDCs: 69344-113-11; 69344-213-11
Sub-potent Drug: Lower potency than labeled.Zyla Life Sciences US Inc. / 3,792 bottlesClass IIIOngoing
D-0084-202410-20-2023Liothyronine Sodium Tablets, USP, 25 mcg, 100-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 62756-590-88
Package NDCs: 62756-589-83; 62756-589-01; 62756-589-88; 62756-589-08; 62756-589-18; 62756-590-83; 62756-590-01; 62756-590-88; 62756-590-08; 62756-590-18; 62756-591-83; 62756-591-01; 62756-591-88; 62756-591-08; 62756-591-18
Failed Impurities/Degradation Specifications.SUN PHARMACEUTICAL INDUSTRIES INC / 2304 BottlesClass IIOngoing
D-0080-202410-20-2023Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-01
Package NDCs: 42799-217-01; 42799-217-02
Subpotent DrugEdenbridge Pharmaceuticals, LLC / 4548 bottlesClass IIIOngoing
D-0097-202410-19-2023Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-256-01.
Package NDCs: 68382-255-06; 68382-255-14; 68382-255-16; 68382-255-01; 68382-255-05; 68382-255-30; 68382-255-77; 68382-256-14; 68382-256-01; 68382-256-16; 68382-256-05; 68382-256-30; 68382-256-77; 68382-256-06; 68382-257-14; 68382-257-01; 68382-257-16; 68382-257-05; 68382-257-30; 68382-257-77; 68382-257-06
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.Zydus Pharmaceuticals (USA) Inc / Class IIOngoing
D-0082-202410-19-2023Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA 01801. NDC# 48433-230-15
Package NDCs: 48433-230-15
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.Safecor Health, LLC / 166,022 bottlesClass IIOngoing
D-0096-202410-19-2023Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01
Package NDCs: 68382-255-06; 68382-255-14; 68382-255-16; 68382-255-01; 68382-255-05; 68382-255-30; 68382-255-77; 68382-256-14; 68382-256-01; 68382-256-16; 68382-256-05; 68382-256-30; 68382-256-77; 68382-256-06; 68382-257-14; 68382-257-01; 68382-257-16; 68382-257-05; 68382-257-30; 68382-257-77; 68382-257-06
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.Zydus Pharmaceuticals (USA) Inc / Class IIOngoing
D-0098-202410-19-2023Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01.
Package NDCs: 68382-255-06; 68382-255-14; 68382-255-16; 68382-255-01; 68382-255-05; 68382-255-30; 68382-255-77; 68382-256-14; 68382-256-01; 68382-256-16; 68382-256-05; 68382-256-30; 68382-256-77; 68382-256-06; 68382-257-14; 68382-257-01; 68382-257-16; 68382-257-05; 68382-257-30; 68382-257-77; 68382-257-06
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.Zydus Pharmaceuticals (USA) Inc / Class IIOngoing
D-0110-202410-18-2023Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-047-03CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.Integrity Bio-Chemicals LLC / 1 55-gallon drumClass IIOngoing
D-0109-202410-18-2023Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 208.19 L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA NDC: 77512-044-03CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.Integrity Bio-Chemicals LLC / 1 55-gallon drumClass IIOngoing
D-0111-202410-18-2023Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum. Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-052-03CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.Integrity Bio-Chemicals LLC / 1-55 gallon drumClass IIOngoing
D-0117-202410-18-2023Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial NDC 51754-2131-1; Carton NDC 51754-2131-4).
Package NDCs: 51754-2130-4; 51754-2131-4; 51754-2131-1
Presence of Particulate Matter: SiliconeExela Pharma Sciences LLC / 23,425 vialsClass IOngoing
D-0118-202410-18-2023ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial: NDC 51754-1007-1; Carton: 51754-1007-3).
Package NDCs: 51754-1007-1; 51754-1007-3
Presence of Particulate Matter: SiliconeExela Pharma Sciences LLC / 38,200 vialsClass IOngoing
D-0116-202410-18-20238.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645; ALSO LABELED 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), c) 20x50 mL Single Dose Vials, (Vial NDC 72572-740-01; Carton NDC 72572-740-20), Rx Only, Mfd for: Civica, Inc., Lehi, Utah, 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
Package NDCs: 51754-5001-5; 51754-5001-4; 51754-5011-4; 51754-5002-5; 51754-5012-4; 72572-740-20; 72572-740-25; 51754-5001-1; 72572-740-01
Presence of Particulate Matter: SiliconeExela Pharma Sciences LLC / 355,220 vialsClass IOngoing
D-0088-202410-17-2023Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11
Package NDCs: 0074-4341-13; 0074-4341-90; 0074-4341-19; 0074-4341-72; 0074-4552-13; 0074-4552-90; 0074-4552-19; 0074-4552-11; 0074-4552-71; 0074-4552-72; 0074-5182-13; 0074-5182-90; 0074-5182-71; 0074-5182-19; 0074-5182-11; 0074-5182-72; 0074-6594-13; 0074-6594-90; 0074-6594-71; 0074-6594-19; 0074-6594-72; 0074-6624-13; 0074-6624-90; 0074-6624-19; 0074-6624-11; 0074-6624-71; 0074-6624-72; 0074-9296-13; 0074-9296-90; 0074-9296-19; 0074-9296-71; 0074-9296-72; 0074-7068-13; 0074-7068-90; 0074-7068-71; 0074-7068-19; 0074-7068-11; 0074-7068-72; 0074-3727-13; 0074-3727-90; 0074-3727-71; 0074-3727-19; 0074-3727-72; 0074-7069-90; 0074-7069-71; 0074-7069-19; 0074-7069-11; 0074-7069-72; 0074-7070-13; 0074-7070-90; 0074-7070-71; 0074-7070-19; 0074-7070-72; 0074-7148-90; 0074-7148-19; 0074-7148-71; 0074-7148-11; 0074-7148-72; 0074-7149-90; 0074-7149-19
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.AbbVie Inc. / 864 cartonsClass IIIOngoing
D-0126-202410-17-2023Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc., Largo, FL 33771, UAS, NDC 66689-330-08
Package NDCs: 66689-330-08
Failed Excipient Specifications: high content of ethylene glycol (EG)VistaPharm LLC / Prod Lot number 22ZKY1, EXP 11/27/23, 600 bottles dist; 22ZMC1 EXP12/21/23 600 bottles; 22ZTP1 EXP 03/29/24 588 bottles; 23ZAD1 EXP 07/07/24 564 bottlClass IIIOngoing
D-0158-202410-16-2023THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33008 UPC 6 61799 95052 7Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.Noah's Wholesale LLC / 173 capsulesClass IOngoing
D-0086-202410-13-2023Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.
Package NDCs: 55111-725-30; 55111-725-90; 55111-725-01; 55111-725-10; 55111-725-79; 55111-725-78; 55111-593-30; 55111-593-90; 55111-593-05; 55111-593-79; 55111-593-78; 55111-594-30; 55111-594-90; 55111-594-05; 55111-594-79; 55111-594-78
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.Dr. Reddy's Laboratories, Inc. / 1,656 bottlesClass IIOngoing
D-0045-202410-05-2023Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.CGMP Deviations: OTC products were stored outside of labeled temperature requirements.Dollar Tree Distribution, Inc. / 4,261,383 units of various productsClass IIOngoing
D-0044-202410-04-2023Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, 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, NDC 47335-737-86
Package NDCs: 47335-736-86; 47335-736-88; 47335-736-08; 47335-736-13; 47335-737-86; 47335-737-88; 47335-737-08; 47335-737-13; 47335-738-86; 47335-738-88; 47335-738-08; 47335-738-13
Failed Dissolution SpecificationsSUN PHARMACEUTICAL INDUSTRIES INC / 144 bottlesClass IIITerminated
D-0071-202410-04-2023VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68.Labeling: Not Elsewhere ClassifiedDenver Solutions, LLC DBA Leiters Health / 33,480 IV BagsClass IIIOngoing
D-0072-202410-04-2023VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68.Labeling: Not Elsewhere ClassifiedDenver Solutions, LLC DBA Leiters Health / 25,908 IV bagsClass IIIOngoing
D-0070-202410-04-2023Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70Labeling: Not Elsewhere ClassifiedDenver Solutions, LLC DBA Leiters Health / 6,276 IV bagsClass IIIOngoing
D-0091-202410-04-2023Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, NDC: 53329-169-79
Package NDCs: 53329-169-79
CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.MEDLINE INDUSTRIES, LP - Northfield / Class IIOngoing
D-0040-202410-03-2023Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 Expires on: 17APR2024. In case of adverse event contact: www.fda.gov/medwatch or (800)-FDA-1088 Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852 (844) 446-6979Subpotent: Failing Test Results for EpinephrineImprimis NJOF, LLC / 364 bags (1 mL filled in 2 mL glass amber vials; 20 vials shipped in a bag)Class IIIOngoing
D-0056-202410-02-2023Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.Lack of Assurance of SterilityPine Pharmaceuticals, LLC / 2484 syringesClass IIOngoing
D-0052-202410-02-2023Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.Lack of Assurance of SterilityPine Pharmaceuticals, LLC / 201 kitsClass IIOngoing
D-0062-202410-02-2023Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.Lack of Assurance of SterilityPine Pharmaceuticals, LLC / 1598 droppersClass IIOngoing
D-0063-202410-02-2023Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.Lack of Assurance of SterilityPine Pharmaceuticals, LLC / 662 dropperClass IIOngoing
D-0053-202410-02-2023Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.Lack of Assurance of SterilityPine Pharmaceuticals, LLC / 128 bagsClass IIOngoing
D-0064-202410-02-2023Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.Lack of Assurance of SterilityPine Pharmaceuticals, LLC / 860 syringesClass IIOngoing
D-0059-202410-02-2023Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.Lack of Assurance of SterilityPine Pharmaceuticals, LLC / 9673 vialsClass IIOngoing
D-0060-202410-02-2023TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.Lack of Assurance of SterilityPine Pharmaceuticals, LLC / 1693 droppersClass IIOngoing
D-0055-202410-02-2023Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.Lack of Assurance of SterilityPine Pharmaceuticals, LLC / 2181 droppersClass IIOngoing
D-0101-202410-02-20231% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4904-11
Package NDCs: 0409-4903-11; 0409-4903-34; 0409-4904-11; 0409-4904-34; 0409-1323-15; 0409-1323-05; 0409-9137-11; 0409-9137-05
Presence of Particulate Matter: identified as glass.Pfizer Inc. / 21,390 vialsClass IOngoing
D-0058-202410-02-2023Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.Lack of Assurance of SterilityPine Pharmaceuticals, LLC / 2176 syringesClass IIOngoing
D-0051-202410-02-2023Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.Lack of Assurance of SterilityPine Pharmaceuticals, LLC / 26 vialsClass IIOngoing
D-0065-202410-02-2023Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.Lack of Assurance of SterilityPine Pharmaceuticals, LLC / 136 syringesClass IIOngoing
D-0050-202410-02-2023Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.Lack of Assurance of SterilityPine Pharmaceuticals, LLC / 2862 SyringesClass IIOngoing
D-0100-202410-02-20234.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24
Package NDCs: 0409-5534-24; 0409-5534-14
Presence of Particulate Matter: identified as glass.Pfizer Inc. / 24,900 vialsClass IOngoing
D-0057-202410-02-2023Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.Lack of Assurance of SterilityPine Pharmaceuticals, LLC / 4972 syringesClass IIOngoing
D-0061-202410-02-2023Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.Lack of Assurance of SterilityPine Pharmaceuticals, LLC / 130Class IIOngoing
D-0102-202410-02-20232% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4903-11
Package NDCs: 0409-4903-11; 0409-4903-34; 0409-4904-11; 0409-4904-34; 0409-1323-15; 0409-1323-05; 0409-9137-11; 0409-9137-05
Presence of Particulate Matter: identified as glass.Pfizer Inc. / 3,200 vialsClass IOngoing
D-0054-202410-02-2023Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.Lack of Assurance of SterilityPine Pharmaceuticals, LLC / 881 pre-filled syringesClass IIOngoing
D-0067-202409-29-2023ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VAMicrobial contamination of Non-Sterile ProductsBiomic Sciences, LLC dba ION Intelligence of Nature / Class IOngoing
D-0069-202409-29-2023Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VAMicrobial contamination of Non-Sterile ProductsBiomic Sciences, LLC dba ION Intelligence of Nature / Class IIOngoing
D-0068-202409-29-2023ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VAMicrobial contamination of Non-Sterile ProductsBiomic Sciences, LLC dba ION Intelligence of Nature / Class IIOngoing
D-0081-202409-28-2023Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01
Package NDCs: 45802-396-01; 45802-396-02
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.Padagis US LLC / 10,512 cartonsClass IIOngoing
D-0041-202409-28-2023Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intra-articular use only, Shake Well, Not for IV/ID, intraocular, epidural, or intrathecal use, Mfd. in India for Auromedics Pharma LLC., E Windsor, NJ, 08520, NDC 55150-385-01.
Package NDCs: 55150-384-01; 55150-385-01
Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.Eugia US LLC / 1,626 vialsClass IIOngoing
D-0042-202409-25-2023BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ 07302 NDC 75788-115-04
Package NDCs: 75788-115-04
Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).Scynexis, Inc. / 17,376Class IOngoing
D-0066-202409-22-2023Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. NDC: 0054-8550-25
Package NDCs: 0054-4550-25; 0054-4550-15; 0054-8550-25
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.West-Ward Columbus Inc / 2,673 cartonsClass IIIOngoing
D-0038-202409-21-2023Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
Package NDCs: 68382-255-06; 68382-255-14; 68382-255-16; 68382-255-01; 68382-255-05; 68382-255-30; 68382-255-77; 68382-256-14; 68382-256-01; 68382-256-16; 68382-256-05; 68382-256-30; 68382-256-77; 68382-256-06; 68382-257-14; 68382-257-01; 68382-257-16; 68382-257-05; 68382-257-30; 68382-257-77; 68382-257-06
Failed Dissolution SpecificationsZydus Pharmaceuticals (USA) Inc / 7,248 bottlesClass IIOngoing
D-0049-202409-20-2023Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01.
Package NDCs: 10702-013-01; 10702-014-01
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.KVK-Tech, Inc. / 1488 bottlesClass IOngoing