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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1004-2020 | 11-13-2019 | Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080 | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API. | Precision Dose Inc. / 224,940 unit dose cups | Class II | Terminated |
| D-0633-2020 | 11-13-2019 | Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 male enhancement capsules in blister foil package, 725mg per capsule, Distributed by Silver Bullet Ltd, Golden Springs, CO, USA, UPC: 610877392698. | Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil. | Natures Rx / 2,800 capsules | Class I | Terminated |
| D-0553-2020 | 11-12-2019 | fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1093-37 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0609-2020 | 11-12-2019 | Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma, LLC, E. Windsor, NJ | Discoloration; Hazy solution found in one vial instead of a clear solution. | AuroMedics Pharma LLC / 59,500 vials | Class II | Terminated |
| D-0550-2020 | 11-12-2019 | fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride Preservative Free, 100 mL in 150 Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1104-36 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0548-2020 | 11-12-2019 | fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478NDC 70092-1259-75 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0558-2020 | 11-12-2019 | fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1100-50 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0572-2020 | 11-12-2019 | fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1274-50 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0563-2020 | 11-12-2019 | fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1094-36 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0546-2020 | 11-12-2019 | fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx only, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1160-37 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0565-2020 | 11-12-2019 | fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride Preservative Free 100 mL in 150 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1103-36 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0568-2020 | 11-12-2019 | fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL in 250 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0549-2020 | 11-12-2019 | fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1269-37 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0556-2020 | 11-12-2019 | fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1097-43 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0567-2020 | 11-12-2019 | fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1444-05 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0559-2020 | 11-12-2019 | fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1255-75 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0564-2020 | 11-12-2019 | fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride 200 mL CADD, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1441-76 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0569-2020 | 11-12-2019 | fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0552-2020 | 11-12-2019 | fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1225-37 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0571-2020 | 11-12-2019 | fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1250-75 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0562-2020 | 11-12-2019 | fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride , 200 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1207-37 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0554-2020 | 11-12-2019 | fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) in 0.9% Sodium Chloride 200 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1440-76 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0551-2020 | 11-12-2019 | fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1099-49 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0566-2020 | 11-12-2019 | fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1415-47 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0555-2020 | 11-12-2019 | fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1092-36 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0560-2020 | 11-12-2019 | fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1098-44 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0557-2020 | 11-12-2019 | fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1202-75 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0547-2020 | 11-12-2019 | fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1105-37 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0570-2020 | 11-12-2019 | fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1180-79 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0561-2020 | 11-12-2019 | fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride , 100 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1108-36 | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules | QuVa Pharma, Inc. / | Class II | Terminated |
| D-0508-2020 | 11-12-2019 | Budesonide 0.4mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401. | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health / N/A | Class II | Terminated |
| D-0512-2020 | 11-12-2019 | Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg, 3ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401. | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health / N/A | Class II | Terminated |
| D-0516-2020 | 11-12-2019 | Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401. | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health / N/A | Class II | Terminated |
| D-0513-2020 | 11-12-2019 | Albuterol 2.5mg / Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401. | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health / N/A | Class II | Terminated |
| D-0509-2020 | 11-12-2019 | Albuterol 3.75mg / Ipratropium 0.75mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401. | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health / N/A | Class II | Terminated |
| D-0514-2020 | 11-12-2019 | Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401. | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health / N/A | Class II | Terminated |
| D-0511-2020 | 11-12-2019 | Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401. | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health / N/A | Class II | Terminated |
| D-0507-2020 | 11-12-2019 | Formoterol 12mcg / Budesonide 0.5mg, 3.5ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 93401. | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health / N/A | Class II | Terminated |
| D-0510-2020 | 11-12-2019 | Albuterol 2.5mg / Ipratropium 0.75mg, 2ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401. | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health / N/A | Class II | Terminated |
| D-0515-2020 | 11-12-2019 | Albuterol 1.25mg / Ipratropium 0.5mg, 2ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401. | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health / N/A | Class II | Terminated |
| D-0573-2020 | 11-11-2019 | Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-165-05. Package NDCs: 80425-0573-1; 0409-1162-18; 55150-165-05; 67777-419-02 | Presence of Foreign Substance: Foreign material found inside the vial. | AuroMedics Pharma LLC / 111,850 vials | Class II | Terminated |
| D-0521-2020 | 11-11-2019 | Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09 Package NDCs: 55150-180-03; 55150-181-09; 55150-182-18 | Crystallization: Presence of visible particulate matter. | AuroMedics Pharma LLC / 29,830 vials | Class III | Terminated |
| D-0520-2020 | 11-11-2019 | Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-180-03 Package NDCs: 55150-180-03; 55150-181-09; 55150-182-18 | Crystallization: Presence of visible particulate matter. | AuroMedics Pharma LLC / 28,810 vials | Class III | Terminated |
| D-0522-2020 | 11-11-2019 | Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-182-18 Package NDCs: 55150-180-03; 55150-181-09; 55150-182-18 | Crystallization: Presence of visible particulate matter. | AuroMedics Pharma LLC / 138,720 vials | Class III | Terminated |
| D-0505-2020 | 11-08-2019 | StellaLife VEGA Oral Gel Rinse (In equal parts of: Azadirachta Indica 1x, Calendula Officinalis 1x, Echinacea Purpurea 1x, Plantago Major 1x), packaged in 1000 mL white plastic bottle. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 1 bottle/ | Class II | Terminated |
| D-0503-2020 | 11-08-2019 | Silicea 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64199 6. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 426 bottles | Class II | Terminated |
| D-0498-2020 | 11-08-2019 | Kali Sulphuricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64196 5. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 295 bottles | Class II | Terminated |
| D-0495-2020 | 11-08-2019 | Ferrum Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64198 9. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 462 bottles | Class II | Terminated |
| D-0501-2020 | 11-08-2019 | Natrum Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64192 7. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 366 bottles | Class II | Terminated |
| D-0492-2020 | 11-08-2019 | Calcarea Phosphorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64189 7. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 681 bottles | Class II | Terminated |
| D-0496-2020 | 11-08-2019 | Kali Muriaticum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64194 1. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 300 bottles | Class II | Terminated |
| D-0493-2020 | 11-08-2019 | Calcarea Sulphurica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64190 3. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 300 bottles | Class II | Terminated |
| D-1037-2020 | 11-08-2019 | Bow & Arrow, Dietary Supplement, Libido Enhancer for Men, a) Four pack, b) Ten pack capsules per carton, Exclusively Manufactured by: Medicine Man Distribution, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783 | Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis. | Med Man Distribution, Inc. / 1880 cartons | Class I | Terminated |
| D-0506-2020 | 11-08-2019 | R2103, Active Ingredients: Berberis Aquifolium 3x; Borax 3; , Kreosotum 10X; Sepia 3x. Inactive ingredient: 28% dilution alcohol, packaged in a) 470 mL bottle and b) 1000 mL bottle; Manufactured for Wisconsin Pharmacal Company, By: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / a) 1 bottle; b) 11 bottles | Class II | Terminated |
| D-0497-2020 | 11-08-2019 | Kali Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64195 8. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 417 bottles | Class II | Terminated |
| D-0494-2020 | 11-08-2019 | Cell Salts Combination 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64200 9. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 829 bottles | Class II | Terminated |
| D-0504-2020 | 11-08-2019 | Pareira (Brava) 1X Tincture, 50 mL bottle, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 1 bottle | Class II | Terminated |
| D-1036-2020 | 11-08-2019 | UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack, c) ten pack capsules per carton, Exclusively Manufactured and Formulated by: Buy Wise Marketing, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783, Ultimatepleasure2.com. | Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis. | Med Man Distribution, Inc. / 1,680 cartons | Class I | Terminated |
| D-0499-2020 | 11-08-2019 | Magnesia Phosphorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64197 2. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 487 bottles | Class II | Terminated |
| D-0500-2020 | 11-08-2019 | Natrum Muriaticum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64191 0. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 366 bottles | Class II | Terminated |
| D-0502-2020 | 11-08-2019 | Natrum Sulphuricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64193 4. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 288 bottles | Class II | Terminated |
| D-0491-2020 | 11-08-2019 | Calcarea Fluorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64188 0. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 489 bottles | Class II | Terminated |
| D-0308-2020 | 11-06-2019 | GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA. | CGMP Deviations: Presence of NDMA impurity detected in product. | Golden State Medical Supply Inc. / N/A | Class II | Terminated |
| D-0307-2020 | 11-06-2019 | GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA. | CGMP Deviations: Presence of NDMA impurity detected in product. | Golden State Medical Supply Inc. / N/A | Class II | Terminated |
| D-0530-2020 | 11-06-2019 | Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05 | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. | AuroMedics Pharma LLC / 26,736 bottles | Class II | Ongoing |
| D-0526-2020 | 11-06-2019 | DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79 | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. | AuroMedics Pharma LLC / 69,696 bottles | Class II | Ongoing |
| D-0529-2020 | 11-06-2019 | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74 | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. | AuroMedics Pharma LLC / 19320 bottles | Class II | Ongoing |
| D-0528-2020 | 11-06-2019 | Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30 | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. | AuroMedics Pharma LLC / 134,160 bottles | Class II | Ongoing |
| D-0527-2020 | 11-06-2019 | Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60 | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. | AuroMedics Pharma LLC / 45,456 bottles | Class II | Ongoing |
| D-0518-2020 | 11-04-2019 | Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: Actavis Laboratories FL. Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-2579-20 Package NDCs: 0591-2579-20 | Presence of foreign substance: Brown/black particles found during stability testing. | Teva Pharmaceuticals USA, Inc. / 3,623 bottles | Class II | Terminated |
| D-0532-2020 | 11-01-2019 | Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by: KVK-Tech, Inc. Newtown PA 18940; NDC 10702-150-16 Package NDCs: 10702-150-16 | Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection | KVK-Tech, Inc. / 1534 bottles | Class II | Terminated |
| D-0306-2020 | 11-01-2019 | Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05 | Presence of Foreign substance: identified as a dead ant. | Lupin Pharmaceuticals Inc. / a) 4074 bottles b) 30,300 bottles | Class III | Terminated |
| D-0305-2020 | 11-01-2019 | Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-723-10 Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05 | Presence of Foreign substance: identified as a dead ant. | Lupin Pharmaceuticals Inc. / 30,516 bottles | Class III | Terminated |
| D-0631-2020 | 11-01-2019 | Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69) | CGMP Deviations: Presence of NDMA impurity detected in product. | American Health Packaging / 1,692 cases of 40 and 50 cups | Class II | Terminated |
| D-0304-2020 | 11-01-2019 | Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02 | Presence of Foreign substance: identified as a dead ant. | Lupin Pharmaceuticals Inc. / 28,254 bottles | Class III | Terminated |
| D-0533-2020 | 10-31-2019 | LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium Metabisulfite - 75 mg, SuturaGel Methlcellulose Base; RX Only, For Prescription Compounding, Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120. NDC: 51552-1539-1 | Microbial contamination of non-sterile product. | Fagron, Inc / 11,912 kits | Class II | Terminated |
| D-0575-2020 | 10-30-2019 | Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical Chemical, packaged in a) 500G glass bottles, product number 3248-01, NDC 10106-3248-1; b) 2.5KG glass bottles, product number 3248-05, NDC 10106-3248-2; c) 12KG pails, product number 3248-07, NDC 10106-3248-3; d) 1KT bottles and drums, product number 3248-X2; e) 1KT bottles and drums, product number 3248-X3; f) 12KG pails, product number 7390-19; Avantor Performance Materials, LLC, 100 Matsonford, Road, Suite 200, Radnor, PA 19087. | Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content. | Avantor Performance Materials Inc / a) 36 bottles; b) 85 bottles; c) 43 pails; d) 28 bottles and drums; e) 100 bottles and drums; f) 4 pails | Class II | Terminated |
| D-0309-2020 | 10-28-2019 | Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80 | CGMP Deviations: Presence of NDMA impurity detected in product. | Lannett Company, Inc. / 683,149 bottles | Class II | Terminated |
| D-0310-2020 | 10-25-2019 | Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20 | CGMP Deviations: Presence of NDMA impurity detected in product. | Novitium Pharma LLC / 19560 bottles | Class II | Terminated |
| D-0312-2020 | 10-25-2019 | Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-10 | CGMP Deviations: Presence of NDMA impurity detected in product. | Novitium Pharma LLC / 12312 bottles | Class II | Terminated |
| D-0313-2020 | 10-25-2019 | Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-40 | CGMP Deviations: Presence of NDMA impurity detected in product. | Novitium Pharma LLC / 6660 bottles | Class II | Terminated |
| D-0350-2020 | 10-25-2019 | 0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25 | Presence of Particulate Matter. | ICU Medical Inc / 58,464 bags | Class I | Terminated |
| D-0349-2020 | 10-25-2019 | LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03 | Presence of Particulate Matter. | ICU Medical Inc / 389,808 bags | Class I | Terminated |
| D-0311-2020 | 10-25-2019 | Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-40 | CGMP Deviations: Presence of NDMA impurity detected in product. | Novitium Pharma LLC / 2718 bottles | Class II | Terminated |
| D-0186-2020 | 10-23-2019 | Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05 | Presence of Foreign Substance | Mylan Pharmaceuticals Inc. / 5,760 bottles | Class II | Terminated |
| D-1013-2020 | 10-23-2019 | Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2; NDC Major: 0904-6715-52; NDC Meijer: 41250-252-72; NDC Sunmark: 49348-136-12; | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1012-2020 | 10-23-2019 | Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-293-65; NDC Equaline 41163-931-65; NDC Family Wellness: 55319-876-65; NDC Good Sense 0113-0876-65; NDC H.E.B.: 37808-876-65; NDC Harris Teeter: 69256-876-65; NDC Health Mart: 62011-0283-1; NDC Leader: 62011-0283-1; NDC Major: 0904-6715-46; NDC Signature Care: 21130-118-65; NDC Sunmark: 49348-136-44; NDC Up & Up: 11673-876-65; NDC Walgreens: 0363-1876-65 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1027-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-01 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1017-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [NDC: Brand] NDC Good Sense:0113-0852-51; NDC Walgreens 0363-0852-51 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1026-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-01; NDC Berkley Jensen: 68391-852-56; NDC: CVS Health: 59779-540-01; NDC DG Health: 55910-011-01; NDC Kirkland: 63981-852-56; NDC Kroger: 30142-600-56; NDC Meijer: 41250-852-01; NDC Rite Aid: 11822-0852-4; NDC Walgreens: 0363-0852-01 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1015-2020 | 10-23-2019 | Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-47 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1023-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC Good Neighbor Pharmacy: 46122-533-09; NDC Kroger: 30142-891-09; NDC Topcare: 36800-950-09; NDC Up & Up: 11673-950-09; NDC Walgreens: 0363-0950-09 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1019-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Care One: 41520-609-62; NDC CVS Health: 59779-950-62; NDC DG Health: 55910-423-62; NDC Equaline: 41163-950-62; NDC Family Wellness: 55319-523-62; NDC Good Neighbor Pharmacy: 46122-041-62; NDC HEB: 37808-710-02; NDC Kroger: 30142-891-02; NDC Leader: 70000-0378-1; NDC Meijer: 41250-950-02; NDC Rite Aid: 11822-0950-0; NDC Shopko: 37012-950-62; NDC Signature Care: 21130-568-62; NDC Topcare: 36800-950-62; NDC Walgreens: 0363-0950-02 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1018-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Being Well: 46994-852-62; NDC Care One 41520-392-02; NDC CVS Health: 59779-540-02; NDC DG Health: 55910-852-02; NDC Equaline: 41163-852-62; NDC Equate: 49035-608-02; NDC Exchange Select: 55301-852-02; NDC Family Wellness: 55319-852-02; NDC Good Neighbor Pharmacy: 46122-224-62; NDC Good Sense 0113-0852-62; NDC Harris Teeter: 69256-041-62; NDC Health Mart 49348-109-04; NDC Kroger 30142-600-02; NDC Major 0904-6716-24; NDC Meijer: 41250-852-02; NDC Publix: 56062-099-02; NDC Rite Aid 11822-0852-5; NDC Select 7: 10202-852-62; NDC Shop Rite 41190-852-62; NDC Shopko: 37012-852-62; NDC Signature Care: 21130-116-02; NDC Sound Body: 50594-852-02; NDC Sunmark: 62011-0282-1; NDC Topcare: 36800-852-02; NDC Up & Up: 11673-023-02; NDC Walgreens: 0363-0852-62 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1021-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per bottle. [Brand, NDC] NDC DG Health: 55910-852-71; NDC Good Neighbor Pharmacy: 46122-224-71; NDC Good Sense: 0113-0852-71; NDC Harris Teeter: 69256-041-71; NDC Kroger: 30142-600-71; NDC Major: 0904-6716-51; NDC Meijer: 41250-852-71; NDC Publix: 56062-099-71; NDC Rite Aid: 11822-0852-2; NDC Signature Care: 21130-116-71; NDC Topcare: 36800-852-71 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1022-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Care One: 41520-392-09; NDC CVS Health: 59779-540-09; NDC Family Wellness: 55319-852-09; NDC Good Neighbor Pharmacy: 46122-532-09; NDC HEB: 37808-507-09; NDC Health Mart: 49348-109-54; NDC Meijer: 41250-891-09; NDC Rite Aid: 11822-0852-3; NDC Shopko: 37012-852-09; NDC Sound Body: 50594-852-09; NDC Sunmark: 49348-109-54; NDC Up & Up: 11673-852-09; NDC Walgreens: 0363-0852-09 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1025-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1020-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1024-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608-75; NDC Up & Up: 11673-023-75 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1028-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82; NDC CVS Health: 59779-540-82; NDC HEB: 37808-507-82; NDC Signature Care: 21130-116-82; NDC Walgreens: 0363-0852-82 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
