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-1509-2020 | 06-23-2020 | BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 54365-400-32 Package NDCs: 54365-400-32 | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides | CareFusion 213, LLC / 12,500 applicators | Class I | Terminated |
| D-1511-2020 | 06-23-2020 | ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01 | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides | CareFusion 213, LLC / 4,272,300 applicators | Class I | Terminated |
| D-1377-2020 | 06-23-2020 | Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99. | Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification. | VistaPharm, Inc. / 380,700 cups | Class III | Terminated |
| D-1381-2020 | 06-23-2020 | Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02 Package NDCs: 64406-007-03; 64406-005-01; 64406-006-02 | cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control. | Biogen MA Inc. / 3,922 bottles | Class III | Terminated |
| D-1378-2020 | 06-23-2020 | Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16. | Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification. | VistaPharm, Inc. / 14,760 bottles | Class III | Terminated |
| D-1510-2020 | 06-23-2020 | ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11 | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides | CareFusion 213, LLC / 2,800,800 applicators | Class I | Terminated |
| D-1407-2020 | 06-22-2020 | Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbiochem SA de CV, Mexico Japon 50, Celaya, Gto., Mexico, 38010. UPC 8 60003 63391 5. | Chemical Contamination: Product contains undeclared methanol. | UVT INC / 38,016 bottles | Class I | Terminated |
| D-1447-2020 | 06-18-2020 | Tasty Drops Hemp Oil Extract, Natural, 1 FL. OZ (30ML) bottles, 500mg CBD, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29084 2 | Chemical Contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 220 bottles | Class I | Completed |
| D-1468-2020 | 06-18-2020 | Acadia Farms, Equilibrium, vermont maple, 300 MG Hemp Oil, 1 Fl OZ (30 ML) bottles, Distributed by: Acadia Farms, Rehobeth, Massachusetts | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 100 bottles | Class I | Completed |
| D-1459-2020 | 06-18-2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Spearmint, 500mg CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, Eau Claire, MI 49111 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 25 bottles | Class I | Completed |
| D-1481-2020 | 06-18-2020 | Goodness Gurus, Healthy Hemp Drops, 1500 MG/Spearmint, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle, PA, UPC 6 53341 99411 0 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 50 bottles | Class I | Completed |
| D-1479-2020 | 06-18-2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Natural, 1000MG CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, Eau Claire, MI 49111 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 25 bottles | Class I | Completed |
| D-1465-2020 | 06-18-2020 | SP, hemp oil, Berry, 300MG CBD,1 FL. OZ (30 ML) bottles, Distributed by: The Spiffy Piff | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 25 bottles | Class I | Completed |
| D-1477-2020 | 06-18-2020 | Tasty Drops, Hemp Oil Extract, Vanilla, 1500MG CBD,1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29086 6 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 100 bottles | Class I | Completed |
| D-1455-2020 | 06-18-2020 | A Clean Choice CBD, Hemp Oil Extract Tincture, Strawberry Creme, 1000mg, 1 fl oz (30 ml) bottles, Made in Michigan for A Clean Choice, A Division of A Clean Cigarette, Inc., 3055 Bay Rd Suite 1, Saginaw, MI 48603 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 350 bottles | Class I | Completed |
| D-1448-2020 | 06-18-2020 | Tasty Drops Hemp Oil Extract, Berry, 1 FL. OZ (30ML) bottles, 300MG CBD, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 8 02991 76469 1 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 213 bottles | Class I | Completed |
| D-1475-2020 | 06-18-2020 | Tasty Drops, Hemp Oil Extract, Spearmint, 1500MG CBD,1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29085 9 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 250 bottles | Class I | Completed |
| D-1482-2020 | 06-18-2020 | Herbzeedy, Hemp Oil Full Spectrum, Natural, 1500 MG CBD, 1 FL OZ (30 ML) bottles, Distributed by: Herbzeedy, Statesboro, GA | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 33 bottles | Class I | Completed |
| D-1462-2020 | 06-18-2020 | Herbzeedy, Hemp Oil Full Spectrum, Natural, 500 MG CBD, 1 FL OZ (30 ML) bottles, Distributed by: Herbzeedy, Statesboro, GA | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 134 bottles | Class I | Completed |
| D-1457-2020 | 06-18-2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Berry Blast, 500mg CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 146, Eau Claire, MI 49111 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 25 bottles | Class I | Completed |
| D-1453-2020 | 06-18-2020 | Made by Hemp 1000MG Hemp Extract, Strawberry Creme, 1 OZ (30 ML) bottles, Dist by: MHR Brands, Jenison, MI, UPC 8 02991 76554 4 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 496 bottles | Class I | Completed |
| D-1470-2020 | 06-18-2020 | Tasty Drops, Hemp Oil Extract, Berry, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29083 5 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 201 bottles | Class I | Completed |
| D-1461-2020 | 06-18-2020 | Goodness Gurus, Healthy Hemp Drops, 500MG/Spearmint, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle, PA, UPC 6 53341 99261 1 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 150 bottles | Class I | Completed |
| D-1473-2020 | 06-18-2020 | Tasty Drops, Hemp Oil Extract, Spearmint, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29081 1 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 366 bottles | Class I | Completed |
| D-1450-2020 | 06-18-2020 | Tasty Drops Hemp Oil Extract, Vanilla, 1 FL. OZ (30ML) bottles, 300MG CBD, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 8 02991 76471 4 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 104 bottles | Class I | Completed |
| D-1478-2020 | 06-18-2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil , Berry Blast, 1000MG CBD, 1 FL. OZ (30ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, Eau Claire, MI 49111 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 50 bottles | Class I | Completed |
| D-1474-2020 | 06-18-2020 | Tasty Drops, Hemp Oil Extract, Spearmint, 1000MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 8 02991 76539 1 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 391 bottles | Class I | Completed |
| D-1452-2020 | 06-18-2020 | Made by Hemp 1000MG Hemp Extract, Mojito Lime, 1 OZ (30 ML) bottles, Dist by: MHR Brandsl, Jenison, M,I UPC 8 02991 76552 0 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 486 bottles | Class I | Completed |
| D-1451-2020 | 06-18-2020 | Made by Hemp 1000MG Hemp Extract, French Vanilla, 1 OZ (30 ML) bottles, Dist by: MHR Brands, Jenison, MI, UPC 8 02991 76553 7 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 495 bottles | Class I | Completed |
| D-1458-2020 | 06-18-2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Natural 500MG CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, Eau Claire, MI 49111 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 72 bottles | Class I | Completed |
| D-1463-2020 | 06-18-2020 | Javan Anti Aging and Wellness Institute, CBD Oil, Full Spectrum Hemp Oil, Spearmint, 300MG CBD, 1 FL. OZ (30 ML) bottles, Dist by: Javan Wellness LLC, 1445 Church St NW Unit 24, Washington, DC 20005 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 100 bottles | Class I | Completed |
| D-1464-2020 | 06-18-2020 | Pathway To Wellness, CBD Oil, Premium Hemp Oil Drops, Natural, 1000MG CBD, 1 FL OZ (30 ML) bottles, Distributed by: Pathway to Wellness | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 100 bottles | Class I | Completed |
| D-1480-2020 | 06-18-2020 | Goodness Gurus, Healthy Hemp Drops Full Strength, 1000 MG/Spearmint, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle, PA, UPC 53341 99311 3 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 50 bottles | Class I | Completed |
| D-1454-2020 | 06-18-2020 | A Clean Choice CBD, Hemp Oil Extract Tincture, French Vanilla, 1000 mg, 1 fl oz (30 ml) bottles, Made in Michigan for A Clean Choice, A Division of A Clean Cigarette, Inc., 3055 Bay Road Suite 1, Saginaw, MI 48603 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 350 bottles | Class I | Completed |
| D-1476-2020 | 06-18-2020 | Tasty Drops, Hemp Oil Extract, Vanilla, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29082 8 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 152 bottles | Class I | Completed |
| D-1466-2020 | 06-18-2020 | SP, hemp oil, Spearmint, 300MG CBD, 1 FL. OZ (30 ML) bottles, Distributed by: The Spiffy Piff | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 25 bottles | Class I | Completed |
| D-1460-2020 | 06-18-2020 | Goodness Gurus, Healthy Hemp Drops, 500MG/Berry, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle, PA, UPC 6 53341 99271 0 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 50 bottles | Class I | Completed |
| D-1472-2020 | 06-18-2020 | Tasty Drops, Hemp Oil Extract, Natural, 1500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29088 0 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 100 bottles | Class I | Completed |
| D-1467-2020 | 06-18-2020 | Recovery Releaf, Pure CBD Oil, Vanilla, 1000MG, 25MG per serving, 1 fl. oz (30 ml) bottles,Distributed by: Recovery Releaf, West Palm Beach, FL | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 100 bottles | Class I | Completed |
| D-1469-2020 | 06-18-2020 | Acadia Farms, Serenity, soothing mint, 300 MG Hemp Oil, 1 Fl OZ (30 ML) bottles, Distributed by: Acadia Farms, Rehobeth, Massachusetts | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 100 bottles | Class I | Completed |
| D-1471-2020 | 06-18-2020 | Tasty Drops, Hemp Oil Extract, Berry, 1500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29087 3 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 150 bottles | Class I | Completed |
| D-1449-2020 | 06-18-2020 | Tasty Drops Hemp Oil Extract, Spearmint, 1 FL. OZ (30ML) bottles, 300MG CBD, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 8 02991 76472 1 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / | Class I | Completed |
| D-1456-2020 | 06-18-2020 | A Clean Choice CBD, Hemp Oil Extract Tincture, Sweet Mint, 500mg, 1 fl oz (30 ml) bottles, Made in Michigan for A Clean Choice, A Division of A Clean Cigarette, Inc., 3055 Bay Rd Suite 1, Saginaw, MI 48603 | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES / 200 bottles | Class I | Completed |
| D-1364-2020 | 06-17-2020 | Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. | Preferred Pharmaceuticals, Inc. / 144 bottles | Class II | Terminated |
| D-1392-2020 | 06-17-2020 | Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Distributed by HF Acquisition Co, LLC, Mukilteo, WA 98275, NDC 63323-739-12 Package NDCs: 63323-739-11; 63323-739-12 | TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state. | HF Acquisition Co. LLC / N/A | Class III | Terminated |
| D-1362-2020 | 06-16-2020 | Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL), Distributed by: Pfizer Madison, NJ 07940, Made in Canada, UPC: 60300312234196, NDC: 0031-2234-19. | Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. | Glaxosmithkline Consumer Healthcare Holdings / 78,132 bottles | Class II | Terminated |
| D-1361-2020 | 06-16-2020 | Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin (expectorant), 4 FL OZ. bottle (118 mL), Distributed by: Pfizer, Madison, NJ 07940 USA, UPC: 50300318760128, NDC: 0031-8760-12. Package NDCs: 0031-8760-12; 5030031876 | Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. | Glaxosmithkline Consumer Healthcare Holdings / 132,336 bottles | Class II | Terminated |
| D-1311-2020 | 06-16-2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46 | Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. | SCA Pharmaceuticals / 333 bags | Class II | Terminated |
| D-1486-2020 | 06-13-2020 | Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients: Oxybenzone 5%, Octisalate 5%, Octinoxate 7.5%, Meradimate 5%, Made in USA | Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate. | Yusef Manufacturing Laboratories, LLC / | Class II | Terminated |
| D-1370-2020 | 06-12-2020 | Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05 Package NDCs: 65862-844-01; 65862-844-05; 65862-844-10; 65862-844-78; 65862-845-01; 65862-845-05; 65862-845-10; 65862-845-78; 65862-846-01; 65862-846-05; 65862-846-10; 65862-846-78; 65862-847-01; 65862-847-05; 65862-847-10; 65862-847-78 | Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg. | Aurobindo Pharma USA Inc. / 1440 bottles | Class II | Terminated |
| D-1359-2020 | 06-12-2020 | Koala Hand Sanitizer, Unscented, 16 FL OZ., Antibacterial, (Ethyl Alcohol 70%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665 | Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol. | Beaming White Llc / N/A | Class II | Terminated |
| D-1360-2020 | 06-12-2020 | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC 00904-5794-61 | CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels. | The Harvard Drug Group / 1,906 Cartons | Class II | Terminated |
| D-1357-2020 | 06-12-2020 | Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl Alcohol 68%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665 | Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol. | Beaming White Llc / N/A | Class II | Terminated |
| D-1358-2020 | 06-12-2020 | Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665 | Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol. | Beaming White Llc / N/A | Class II | Terminated |
| D-1308-2020 | 06-11-2020 | Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9701-01 Package NDCs: 0143-9702-01; 0143-9701-01 | Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. | Hikma Pharmaceuticals USA Inc. / 82,426 vials | Class II | Terminated |
| D-1309-2020 | 06-11-2020 | Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9583-01 Package NDCs: 0143-9583-01 | Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. | Hikma Pharmaceuticals USA Inc. / 17,998 vials | Class II | Terminated |
| D-1334-2020 | 06-11-2020 | Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-336-07) | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Lupin Pharmaceuticals Inc. / 6,540 bottles | Class II | Terminated |
| D-1339-2020 | 06-10-2020 | Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-15 Package NDCs: 0316-0221-15; 0316-0221-30 | Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP. | Crown Laboratories / 35,931 tubes | Class II | Terminated |
| D-1341-2020 | 06-10-2020 | Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA, NDC 62332-097-30. Package NDCs: 62332-097-30; 62332-097-71; 62332-097-91; 62332-097-31; 62332-097-10; 62332-098-30; 62332-098-31; 62332-098-91; 62332-098-10; 62332-098-71; 62332-099-30; 62332-099-31; 62332-099-71; 62332-099-91; 62332-099-10; 62332-100-30; 62332-100-31; 62332-100-71; 62332-100-91; 62332-100-10; 62332-101-30; 62332-101-31; 62332-101-71; 62332-101-91; 62332-101-10; 62332-102-30; 62332-102-31; 62332-102-71; 62332-102-91; 62332-102-10; 1905003298 | Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count. | Alembic Pharmaceuticals Limited / 19,153 bottles | Class II | Terminated |
| D-1338-2020 | 06-10-2020 | Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-30 Package NDCs: 0316-0221-15; 0316-0221-30 | Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP. | Crown Laboratories / 62,274 tubes | Class II | Terminated |
| D-1372-2020 | 06-10-2020 | Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC carton: 60687-374-01, NDC unit dose: 60687-374-11 | Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label. | American Health Packaging / 265 cartons | Class III | Terminated |
| D-1363-2020 | 06-09-2020 | Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a compounded drug not for resale, Store at room temperature, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419. | Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin. | MasterPharm LLC / 300 capsules | Class I | Terminated |
| D-1340-2020 | 06-05-2020 | Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-040-04 | Discoloration: Out of Specification (OOS) result for APHA Color Test. | Akorn, Inc. / 17,424 bottles | Class III | Terminated |
| D-1333-2020 | 06-05-2020 | metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC 72789-009-93); e) 100 tablets (NDC 49483-0623-01) bottles, Rx only PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127 Package NDCs: 72789-009-30; 72789-009-60; 72789-009-90; 72789-009-93; 49483-0623-01 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | PD-Rx Pharmaceuticals, Inc. / 1969 bottles | Class II | Terminated |
| D-1356-2020 | 06-05-2020 | Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No, L-82, L-83, Verna Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01 Package NDCs: 49483-623-09; 49483-623-01; 49483-623-50; 49483-623-10; 49483-624-01; 49483-624-50 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Marksans Pharma Limited / 11279 bottles | Class II | Terminated |
| D-1307-2020 | 06-05-2020 | metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 43063-428-90); d) 120 tablets (NDC: 43063-428-98); e) 180 tablets (NDC: 43063-428-93); f) 500 tablets (NDC: 53746-0178-05), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | PD-Rx Pharmaceuticals, Inc. / 3703 bottles | Class II | Terminated |
| D-1304-2020 | 06-04-2020 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | AVKARE Inc. / 88,545 bottles | Class II | Terminated |
| D-1305-2020 | 06-04-2020 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610-90); c) 180 count (NDC 42291-610-18); d) 360 count (NDC 42291-610-36); e) 1000 count (NDC 42291-610-10) bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | AVKARE Inc. / 1,586,913 bottles | Class II | Terminated |
| D-1375-2020 | 06-04-2020 | Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-233-01 Package NDCs: 70069-231-01; 70069-232-01; 70069-233-01 | Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life. | SOMERSET THERAPEUTICS LLC / 22,788 bottles | Class III | Terminated |
| D-1373-2020 | 06-04-2020 | Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-231-01 Package NDCs: 70069-231-01; 70069-232-01; 70069-233-01 | Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life. | SOMERSET THERAPEUTICS LLC / 383,437 bottles | Class III | Terminated |
| D-1374-2020 | 06-04-2020 | Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-232-01 Package NDCs: 70069-231-01; 70069-232-01; 70069-233-01 | Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life. | SOMERSET THERAPEUTICS LLC / 48,852 bottles | Class III | Terminated |
| D-1540-2020 | 06-03-2020 | Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz Tube, Rocky Mtn. Sunscreen, UPC 7 54018 20004 3 | Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim. | Yusef Manufacturing Laboratories, LLC / 2,558 pieces | Class II | Terminated |
| D-1337-2020 | 06-03-2020 | Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL), A.P. Deauville LLC New Brunswick, NJ 08901, NDC 42913-020-00, UPC 815195014097 | cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications. | A.P. Deauville, LLC / 82,800 bottles | Class II | Terminated |
| D-1416-2020 | 06-03-2020 | Walker Emulsions Hand Sanitizer (60%), Non-Sterile Solution, Alcohol Antiseptic 60%, 1 Gallon, Topical Solution, Walker Emulsions Inc., 4401 SE Johnson Creek Blvd., Portland, OR 97222, NDC 74940-0415-1 | Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer. | WALKER EMULSIONS INC / N/A | Class II | Terminated |
| D-1417-2020 | 06-03-2020 | Walker Hand Sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70%, 32 oz and 16 oz, Topical Solution, Walker Emulsions Inc., 4401 SE Johnson Creek Blvd., Portland, OR 97222, NDC 74940-0415-1 | Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer. | WALKER EMULSIONS INC / N/A | Class II | Terminated |
| D-1331-2020 | 06-02-2020 | Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Teva Pharmaceuticals USA / a) 92,793 bottles and b) 4,824 bottles | Class II | Terminated |
| D-1332-2020 | 06-02-2020 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Teva Pharmaceuticals USA / a) 15,329 bottles and b) 137 bottles | Class II | Terminated |
| D-1411-2020 | 06-01-2020 | Handese Advanced Instant Hand Sanitizer (Ethyl Alcohol 70%), 12 FL OZ (354 mL) bottles, www.handeseclean.com UPC 612520481094 | Subpotent Drug: Product was found to be subpotent. Product also has high pH levels | WORLD EVENT PROMOTIONS, LLC / 14050 bottles | Class II | Terminated |
| D-1393-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1343-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-01 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / 192 | Class II | Ongoing |
| D-1352-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1348-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-01 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1354-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1351-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1353-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-0178-11 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1350-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1345-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-50 Package NDCs: 65162-178-89; 65162-178-03; 65162-178-09; 65162-178-10; 65162-178-50; 65162-178-11; 65162-179-03; 65162-179-09; 65162-179-10; 65162-179-50 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1349-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-179-10 Package NDCs: 65162-178-89; 65162-178-03; 65162-178-09; 65162-178-10; 65162-178-50; 65162-178-11; 65162-179-03; 65162-179-09; 65162-179-10; 65162-179-50 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1344-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08907 NDC 65162-178-09 Package NDCs: 65162-178-89; 65162-178-03; 65162-178-09; 65162-178-10; 65162-178-50; 65162-178-11; 65162-179-03; 65162-179-09; 65162-179-10; 65162-179-50 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1347-2020 | 05-29-2020 | amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213 India Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-10 Package NDCs: 65162-178-89; 65162-178-03; 65162-178-09; 65162-178-10; 65162-178-50; 65162-178-11; 65162-179-03; 65162-179-09; 65162-179-10; 65162-179-50 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Amneal Pharmaceuticals of New York, LLC / N/A | Class II | Ongoing |
| D-1306-2020 | 05-29-2020 | Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, carton NDC 0049-0013-83 Package NDCs: 0049-0013-81; 0049-0013-83; 0049-0014-81; 0049-0014-83; 0049-0710-01; 0049-0710-10; 0049-3003-01; 0049-3003-10 | Presence of Particulate Matter: particulate matter identified after reconstitution. | Pfizer Inc. / 94320 units | Class II | Terminated |
| D-1325-2020 | 05-28-2020 | Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single pack and twin pack, Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0095-41 Package NDCs: 0135-0094-41; 0135-0094-42; 0135-0095-41; 0135-0574-01 | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. | Glaxosmithkline Consumer Healthcare Holdings / 1,631,700 bottles & 27,300 Twin-Pack botles | Class II | Terminated |
| D-1323-2020 | 05-28-2020 | Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-41 Package NDCs: 0135-0094-41; 0135-0094-42; 0135-0095-41; 0135-0574-01 | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. | Glaxosmithkline Consumer Healthcare Holdings / 151,344 bottles | Class II | Terminated |
| D-1322-2020 | 05-28-2020 | Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-42 Package NDCs: 0135-0094-41; 0135-0094-42; 0135-0095-41; 0135-0574-01 | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. | Glaxosmithkline Consumer Healthcare Holdings / 119,364 bottles | Class II | Terminated |
| D-1290-2020 | 05-28-2020 | Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03. Package NDCs: 68180-512-02; 68180-512-30; 68180-512-09; 68180-512-01; 68180-512-03; 68180-513-30; 68180-513-03; 68180-513-01; 68180-513-09; 68180-513-02; 68180-513-05; 68180-517-03; 68180-517-01; 68180-517-30; 68180-517-09; 68180-517-04; 68180-517-02; 68180-980-03; 68180-980-30; 68180-980-01; 68180-980-09; 68180-980-05; 68180-980-02; 68180-981-01; 68180-981-03; 68180-981-30; 68180-981-09; 68180-981-02; 68180-981-05; 68180-982-01; 68180-982-02; 68180-982-30; 68180-982-03; 68180-982-09; 68180-979-01; 68180-979-03; 68180-979-30; 68180-979-09; 68180-514-01; 68180-514-02; 68180-514-03; 68180-514-09; 68180-514-30; 68180-514-05; 68180-515-01; 68180-515-02; 68180-515-03; 68180-515-09; 68180-515-30; 68180-515-05; 68180-516-01; 68180-516-02; 68180-516-03; 68180-516-09; 68180-516-30 | Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle. | Lupin Pharmaceuticals Inc. / 4,224 bottles | Class II | Terminated |
| D-1302-2020 | 05-28-2020 | oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 888-339-0874, NDC 70092-1068-07 | Subpotent drug - Product did not contain drug. | QuVa Pharma, Inc. / 648 bags | Class II | Terminated |
| D-1324-2020 | 05-28-2020 | Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0574-41 | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. | Glaxosmithkline Consumer Healthcare Holdings / 629,796 bottles | Class II | Terminated |
| D-1289-2020 | 05-28-2020 | Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478. Package NDCs: 42291-366-01; 42291-366-10; 42291-367-01; 42291-367-10; 42291-368-60; 42291-368-50; 42291-369-60; 42291-369-50 | Presence of Foreign Substance consistent with granules from desiccant packs used during storage | AVKARE Inc. / 4124 bottles | Class III | Terminated |
| D-1342-2020 | 05-27-2020 | Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx Only, Distributed by Wyeth Pharmaceuticals LLC A subsidiary of Pfizer In Philadelphia, PA 19101 Made in Ireland, NDC 00008-1123-12 | Failed Dissolution Specifications | Pfizer Inc. / 544400 packages | Class III | Terminated |
| D-1303-2020 | 05-27-2020 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels | Apotex Inc. / 305,963 bottles | Class II | Completed |
