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 April 12, 2024 and include a total of 16143 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0396-2024 | 11-09-2023 | fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 500 bags | Class II | Ongoing |
| D-0401-2024 | 11-09-2023 | fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0251-64, Bar Code 70004025164 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 130 cassettes | Class II | Ongoing |
| D-0405-2024 | 11-09-2023 | HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-16, Bar Code 70004030016 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 5,734 syringes | Class II | Ongoing |
| D-0417-2024 | 11-09-2023 | PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022. | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 5,948 syringes, expanded 2,102 syringes | Class II | Ongoing |
| D-0400-2024 | 11-09-2023 | fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0289-64, Bar Code 70004028964 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 412 cassettes | Class II | Ongoing |
| D-0414-2024 | 11-09-2023 | PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 70004081012 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 33,072 syringes; expanded 9,041 syringes | Class II | Ongoing |
| D-0418-2024 | 11-09-2023 | PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0811-12, Bar Code 70004081112. | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 10,017 syringes, expanded 2579 syringes | Class II | Ongoing |
| D-0416-2024 | 11-09-2023 | PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID for KitCheck | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 1,118 syringes in kits | Class II | Ongoing |
| D-0424-2024 | 11-09-2023 | SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-09, Bar Code 70004090809 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 5,079 syringe | Class II | Ongoing |
| D-0407-2024 | 11-09-2023 | HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 1,023 syringes | Class II | Ongoing |
| D-0419-2024 | 11-09-2023 | PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540. | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 400 bags | Class II | Ongoing |
| D-0425-2024 | 11-09-2023 | VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 368 bags | Class II | Ongoing |
| D-0398-2024 | 11-09-2023 | fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-64, Bar Code 70004023164 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 613 Cassettes | Class II | Ongoing |
| D-0413-2024 | 11-09-2023 | neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 1,122 syringes | Class II | Ongoing |
| D-0402-2024 | 11-09-2023 | fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0200-17, Bar code 70004020017 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 1,259 syringes | Class II | Ongoing |
| D-0422-2024 | 11-09-2023 | Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 70004090025 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 9,624 syringes | Class II | Ongoing |
| D-0420-2024 | 11-09-2023 | PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code 700040081612. | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 3,671 syringes, expanded 1,911 syringes | Class II | Ongoing |
| D-0411-2024 | 11-09-2023 | labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 2,458, syringes | Class II | Ongoing |
| D-0395-2024 | 11-09-2023 | fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 BAR code 70004022940 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 548 bags | Class II | Ongoing |
| D-0408-2024 | 11-09-2023 | HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 7004030317 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 399 syringes | Class II | Ongoing |
| D-0421-2024 | 11-09-2023 | PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12-K, Bar Code 700040081612. (same finished product as F078140, but with RFID for KitCheck compatibility) | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 2,427 syringes | Class II | Ongoing |
| D-0412-2024 | 11-09-2023 | Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 1,508 bags; expanded 1,015 bags | Class II | Ongoing |
| D-0399-2024 | 11-09-2023 | fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-0231-22, Bar Code 70004023122 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 324 syringes | Class II | Ongoing |
| D-0403-2024 | 11-09-2023 | fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, Bar code 70004020022, | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 500 syringes | Class II | Ongoing |
| D-0406-2024 | 11-09-2023 | HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 70004030018 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 1,425 syringes | Class II | Ongoing |
| D-0404-2024 | 11-09-2023 | HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar Code 70004030063 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 256 cassettes | Class II | Ongoing |
| D-0140-2024 | 11-09-2023 | LET 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, NDC73271-1003-1 | Product Mix-up: Incorrect Product Formulation | Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop / 190 syringes | Class III | Ongoing |
| D-0138-2024 | 11-08-2023 | Dr. 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 glyburide | SUGARMDS LLC / 32,117 | Class I | Ongoing |
| D-0123-2024 | 11-07-2023 | Indomethacin 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 Naproxen | Glenmark Pharmaceuticals Inc., USA / 37,200 bottles | Class II | Ongoing |
| D-0124-2024 | 11-07-2023 | Naproxen 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 Naproxen | Glenmark Pharmaceuticals Inc., USA / | Class II | Ongoing |
| D-0145-2024 | 11-06-2023 | VITRAKVI (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 testing | Bayer Healthcare Pharmaceuticals Inc. / 192 bottles | Class I | Ongoing |
| D-0089-2024 | 11-06-2023 | Hydrocortisone 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 bottles | Class III | Ongoing |
| D-0121-2024 | 11-01-2023 | Paroxetine 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 Paroxetine | Apotex Corp. / 25,776 | Class II | Ongoing |
| D-0120-2024 | 11-01-2023 | Paroxetine 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 Paroxetine | Apotex Corp. / 48,623 | Class II | Ongoing |
| D-0122-2024 | 11-01-2023 | Paroxetine 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 Paroxetine | Apotex Corp. / 4,074 | Class II | Ongoing |
| D-0119-2024 | 11-01-2023 | Paroxetine 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 Paroxetine | Apotex Corp. / 34,392 | Class II | Ongoing |
| D-0139-2024 | 11-01-2023 | Trospium 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 capsules | Padagis US LLC / 7,032 bottles | Class II | Ongoing |
| D-0131-2024 | 10-31-2023 | LEADER 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: 70000-0087-1 | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. | Cardinal Health Inc. / 11629 units | Class I | Ongoing |
| D-0134-2024 | 10-31-2023 | LEADER 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 cartons | Class I | Ongoing |
| D-0107-2024 | 10-31-2023 | Polyvinyl 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 bottles | Class I | Ongoing |
| D-0133-2024 | 10-31-2023 | LEADER 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: 70000-0090-1 | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. | Cardinal Health Inc. / 119,871 bottles | Class I | Ongoing |
| D-0136-2024 | 10-31-2023 | LEADER 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: 70000-0587-1 | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. | Cardinal Health Inc. / 8,784 bottles | Class I | Ongoing |
| D-0135-2024 | 10-31-2023 | LEADER 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: 70000-0088-1 | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. | Cardinal Health Inc. / 11,782 bottles | Class I | Ongoing |
| D-0132-2024 | 10-31-2023 | LEADER 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: 70000-0089-1 | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. | Cardinal Health Inc. / 21,802 bottles | Class I | Ongoing |
| D-0108-2024 | 10-31-2023 | Lubricating 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 0536-1282-94 | 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 / 65,880 bottles | Class I | Ongoing |
| D-0099-2024 | 10-30-2023 | V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd., Melbourne, FL 32935 | Incorrect 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 bottles | Class III | Completed |
| D-0114-2024 | 10-27-2023 | Lisinopril 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 lots | NCS Healthcare of Kentucky Inc / 12 cards | Class III | Ongoing |
| D-0113-2024 | 10-27-2023 | Buspirone 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 lots | NCS Healthcare of Kentucky Inc / 1,344 cards | Class III | Ongoing |
| D-0093-2024 | 10-26-2023 | Mycophenolate 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 bottles | Class III | Ongoing |
| D-0153-2024 | 10-23-2023 | Phenytoin 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 Specifications | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 3718 saleable units | Class I | Ongoing |
| D-0112-2024 | 10-23-2023 | Esomeprazole 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 bottles | Class III | Ongoing |
| D-0092-2024 | 10-23-2023 | Ranolazine 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 bottles | Class II | Ongoing |
| D-0225-2024 | 10-20-2023 | Reumo 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 014598 | Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. | Botanical Be / | Class I | Ongoing |
| D-0224-2024 | 10-20-2023 | Artri 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 111138 | Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. | Botanical Be / 235 bottles | Class I | Ongoing |
| D-0226-2024 | 10-20-2023 | Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265 | Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. | Botanical Be / 300 bottles | Class I | Ongoing |
| D-0085-2024 | 10-20-2023 | Bisoprolol 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 Specifications | Glenmark Pharmaceuticals Inc., USA / 480 100-count bottles | Class III | Ongoing |
| D-0095-2024 | 10-20-2023 | Deferasirox 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 Specifications | Glenmark Pharmaceuticals Inc., USA / 5,856 bottles | Class II | Ongoing |
| D-0115-2024 | 10-20-2023 | Tiglutik (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 viscosity | ITF PHARMA INC / 1,792 bottles | Class II | Ongoing |
| D-0105-2024 | 10-20-2023 | Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9 | Sub 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 bottles | Class II | Ongoing |
| D-0103-2024 | 10-20-2023 | DOP 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 4 | Sub 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 bottles | Class II | Ongoing |
| D-0094-2024 | 10-20-2023 | Oxaydo (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 bottles | Class III | Ongoing |
| D-0104-2024 | 10-20-2023 | DOP 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 4 | Sub 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 bottles | Class II | Ongoing |
| D-0080-2024 | 10-20-2023 | Opium 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 Drug | Edenbridge Pharmaceuticals, LLC / 4548 bottles | Class III | Ongoing |
| D-0083-2024 | 10-20-2023 | Liothyronine 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 Bottles | Class II | Ongoing |
| D-0084-2024 | 10-20-2023 | Liothyronine 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 Bottles | Class II | Ongoing |
| D-0082-2024 | 10-19-2023 | Strong 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 bottles | Class II | Ongoing |
| D-0098-2024 | 10-19-2023 | Oxybutynin 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 II | Ongoing |
| D-0097-2024 | 10-19-2023 | Oxybutynin 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 II | Ongoing |
| D-0096-2024 | 10-19-2023 | Oxybutynin 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 II | Ongoing |
| D-0109-2024 | 10-18-2023 | Integrity 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: 77512-044-03 | CGMP 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 drum | Class II | Ongoing |
| D-0110-2024 | 10-18-2023 | Integrity 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: 77512-047-03 | CGMP 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 drum | Class II | Ongoing |
| D-0111-2024 | 10-18-2023 | Integrity 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: 77512-052-03 | CGMP 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 drum | Class II | Ongoing |
| D-0117-2024 | 10-18-2023 | Midazolam 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: Silicone | Exela Pharma Sciences LLC / 23,425 vials | Class I | Ongoing |
| D-0118-2024 | 10-18-2023 | ELCYS (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: Silicone | Exela Pharma Sciences LLC / 38,200 vials | Class I | Ongoing |
| D-0116-2024 | 10-18-2023 | 8.4% 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: Silicone | Exela Pharma Sciences LLC / 355,220 vials | Class I | Ongoing |
| D-0088-2024 | 10-17-2023 | Synthroid, 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 cartons | Class III | Ongoing |
| D-0126-2024 | 10-17-2023 | Aminocaproic 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 | 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 bottl | Class III | Ongoing |
| D-0158-2024 | 10-16-2023 | THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33008 UPC 6 61799 95052 7 | Marketed 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 capsules | Class I | Ongoing |
| D-0086-2024 | 10-13-2023 | Montelukast 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 bottles | Class II | Ongoing |
| D-0045-2024 | 10-05-2023 | Certain 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 products | Class II | Ongoing |
| D-0044-2024 | 10-04-2023 | Bupropion 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 Specifications | SUN PHARMACEUTICAL INDUSTRIES INC / 144 bottles | Class III | Terminated |
| D-0091-2024 | 10-04-2023 | Clinical 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 II | Ongoing |
| D-0071-2024 | 10-04-2023 | VANCOmycin 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 Classified | Denver Solutions, LLC DBA Leiters Health / 33,480 IV Bags | Class III | Ongoing |
| D-0070-2024 | 10-04-2023 | Oxytocin 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 71449-157-70 | Labeling: Not Elsewhere Classified | Denver Solutions, LLC DBA Leiters Health / 6,276 IV bags | Class III | Ongoing |
| D-0072-2024 | 10-04-2023 | VANCOmycin 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 Classified | Denver Solutions, LLC DBA Leiters Health / 25,908 IV bags | Class III | Ongoing |
| D-0040-2024 | 10-03-2023 | Epinephrine-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) 446-6979 | Subpotent: Failing Test Results for Epinephrine | Imprimis NJOF, LLC / 364 bags (1 mL filled in 2 mL glass amber vials; 20 vials shipped in a bag) | Class III | Ongoing |
| D-0101-2024 | 10-02-2023 | 1% 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 vials | Class I | Ongoing |
| D-0100-2024 | 10-02-2023 | 4.2% 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 vials | Class I | Ongoing |
| D-0102-2024 | 10-02-2023 | 2% 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 vials | Class I | Ongoing |
| D-0065-2024 | 10-02-2023 | Foscarnet 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 Sterility | Pine Pharmaceuticals, LLC / 136 syringes | Class II | Completed |
| D-0051-2024 | 10-02-2023 | Vancomycin 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 Sterility | Pine Pharmaceuticals, LLC / 26 vials | Class II | Completed |
| D-0063-2024 | 10-02-2023 | Tropi-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 Sterility | Pine Pharmaceuticals, LLC / 662 dropper | Class II | Completed |
| D-0062-2024 | 10-02-2023 | Lidocaine 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 Sterility | Pine Pharmaceuticals, LLC / 1598 droppers | Class II | Completed |
| D-0061-2024 | 10-02-2023 | Calcium 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 Sterility | Pine Pharmaceuticals, LLC / 130 | Class II | Completed |
| D-0058-2024 | 10-02-2023 | Moxifloxacin 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 Sterility | Pine Pharmaceuticals, LLC / 2176 syringes | Class II | Completed |
| D-0056-2024 | 10-02-2023 | Moxifloxacin 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 Sterility | Pine Pharmaceuticals, LLC / 2484 syringes | Class II | Completed |
| D-0052-2024 | 10-02-2023 | Endophth 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 Sterility | Pine Pharmaceuticals, LLC / 201 kits | Class II | Completed |
| D-0053-2024 | 10-02-2023 | Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 128 bags | Class II | Completed |
| D-0059-2024 | 10-02-2023 | Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 9673 vials | Class II | Completed |
| D-0060-2024 | 10-02-2023 | TPC 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 Sterility | Pine Pharmaceuticals, LLC / 1693 droppers | Class II | Completed |