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-0376-2021 | 04-26-2021 | Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-0045-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 7,564/1 multiple dose vial per carton | Class II | Terminated |
| D-0374-2021 | 04-26-2021 | Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc., Irvine, CA NDC 0703-5145-01; ALSO LABELED UNDER: NOVAPLUS, Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-5145-91 (Novaplus, a registered trademark of Vizient, Inc.) | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 192,277 cartons/1 single dose vial per carton | Class II | Terminated |
| D-0378-2021 | 04-26-2021 | Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 7020 vials | Class II | Terminated |
| D-0375-2021 | 04-26-2021 | Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 3150 vials | Class II | Terminated |
| D-0367-2021 | 04-21-2021 | Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-227-01. Packaged in 150 cc white HDPE bottle Package NDCs: 23155-227-01; 23155-227-05; 23155-228-01; 23155-228-05 | Labeling: Incorrect or Missing Lot and/or Exp Date | Heritage Pharmaceuticals Inc / 408 bottles | Class III | Terminated |
| D-0373-2021 | 04-20-2021 | BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-38 Package NDCs: 54365-400-38 | Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution. | CareFusion 213, LLC / 707,050 eaches | Class I | Terminated |
| D-0357-2021 | 04-20-2021 | Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech, Inc. NDC:50242-175-05 | Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes. | Genentech Inc / 2,627 bottles | Class III | Terminated |
| D-0379-2021 | 04-19-2021 | Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10. Package NDCs: 42794-016-22; 42794-016-08; 42794-016-10; 42794-017-22; 42794-017-08; 42794-017-10 | Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent | SigmaPharm Laboratories LLC / 6266 bottles | Class III | Terminated |
| D-0380-2021 | 04-19-2021 | Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10 Package NDCs: 42794-016-22; 42794-016-08; 42794-016-10; 42794-017-22; 42794-017-08; 42794-017-10 | Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent | SigmaPharm Laboratories LLC / 8786 bottles | Class III | Terminated |
| D-0336-2021 | 04-16-2021 | Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6675-8 Package NDCs: 68968-6625-8; 68968-6637-8; 68968-6650-8; 68968-6675-8; 68968-6610-8 | Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin. | Noven Pharmaceuticals Inc / 12060 cartons | Class II | Terminated |
| D-0337-2021 | 04-16-2021 | Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-3437-8 Package NDCs: 68968-3425-8; 68968-3437-8; 68968-3450-8; 68968-3475-8; 68968-3410-8 | Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin. | Noven Pharmaceuticals Inc / 10872 cartons | Class II | Terminated |
| D-0355-2021 | 04-15-2021 | Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder; c) D Medical Gas Cylinder; d) E Medical Gas Cylinder; e) M Medical Gas Cylinder; f) H Medical Gas Cylinder, Rx only, Grace Healthcare 1418 31st Avenue Gulfport, MS 39501 228-863-3331 | cGMP deviations | Grace Healthcare Medical, Inc / 35,838 cylinders | Class II | Terminated |
| D-0389-2021 | 04-14-2021 | Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451 | Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box. | Fresenius Medical Care, North America / 709 cases | Class II | Terminated |
| D-0387-2021 | 04-13-2021 | Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2 Strips Each), Manufactured by: Nomax, Inc, St. Louis, MO 63123, NDC: 51801-008-15 Package NDCs: 51801-008-15 | Subpotent Drug | Nomax Inc / 78 cartons | Class III | Terminated |
| D-0335-2021 | 04-12-2021 | Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178 | Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility | Edge Pharma, LLC / 5850 syringes | Class II | Terminated |
| D-0342-2021 | 04-12-2021 | Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100, Rx only, Repackaged by Preferred Pharmaceuticals, Inc., Mfg: Ascend Laboratories, LLC, NDC #: 68788-7529-1, Package NDCs: 68788-7529-1; 68788-7529-2 | Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin | Preferred Pharmaceuticals, Inc. / Six bottles | Class II | Ongoing |
| D-0356-2021 | 04-09-2021 | Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60 | Failed Impurities/Degradation Specifications: | Teligent Pharma, Inc. / 3432 tubes | Class II | Ongoing |
| D-0641-2021 | 04-08-2021 | Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 32555 7 | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil | NSNY Distributor Inc / 2600 capsules | Class I | Ongoing |
| D-0642-2021 | 04-08-2021 | Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010, UPC 0 40232 18144 3 | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil | NSNY Distributor Inc / 399 capsules | Class I | Ongoing |
| D-0382-2021 | 04-06-2021 | PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. | Hyobin LLC / 500 cards | Class II | Ongoing |
| D-0383-2021 | 04-06-2021 | Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. | Hyobin LLC / 300 cards | Class II | Ongoing |
| D-0381-2021 | 04-06-2021 | PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. | Hyobin LLC / 500 cards | Class II | Ongoing |
| D-0333-2021 | 04-01-2021 | Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-282-30. | Failed Dissolution Specifications | Jubilant Cadista Pharmaceuticals, Inc. / Lot #IT119008B - (4,128 Bottles); Lot #IT20001A - (3,984 Bottles); Lot #IT20002B - (4.080 Bottles) | Class II | Terminated |
| D-0370-2021 | 03-31-2021 | Burro en Primavera, 2 capsules, UPC 638632431055 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. | QMart / 500 boxes | Class II | Ongoing |
| D-0371-2021 | 03-31-2021 | Imperial Platinum 2000, 1 capsule, UPC 718122040702 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. | QMart / 200 boxes | Class II | Ongoing |
| D-0369-2021 | 03-31-2021 | PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC 728175421887 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. | QMart / 500 boxes | Class II | Ongoing |
| D-0368-2021 | 03-31-2021 | IMPERIAL GOLD 2000, Male Sexual Performance Enhancement, 1 Capsule, UPC 718122040702 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. | QMart / 200 boxes | Class II | Ongoing |
| D-0324-2021 | 03-31-2021 | Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-3928-1, UPC 3 60505 39281 0 Package NDCs: 60505-3927-3; 60505-3927-1; 60505-3927-8; 60505-3928-3; 60505-3928-1; 60505-3928-8; 60505-3929-3; 60505-3929-1; 60505-3929-8; 60505-3930-3; 60505-3930-1; 60505-3930-8 | Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate | Apotex Corp. / 55620 bottles | Class II | Ongoing |
| D-0334-2021 | 03-31-2021 | Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactured by: Mikart, LLC, Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 10631-206-02. Package NDCs: 10631-238-01; 10631-238-02; 10631-206-01; 10631-206-02 | Microbial Contamination of Non-Sterile Product | SUN PHARMACEUTICAL INDUSTRIES INC / 13,834 bottles | Class II | Terminated |
| D-0353-2021 | 03-30-2021 | PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. | Na Na Collection / N/A | Class II | Ongoing |
| D-0662-2021 | 03-30-2021 | Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860 | Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall. | Ummzy, LLC / N/A | Class I | Terminated |
| D-0354-2021 | 03-30-2021 | Triple SupremeZen Gold 3500, Packaged in paper packaging with a pill blister,1 capsule per box, Distributed by VIEW LIFE Distributors Los Angeles CA 90005 UPC 7 15122 05089 4 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. | Na Na Collection / N/A | Class II | Ongoing |
| D-0663-2021 | 03-30-2021 | Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185 | Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall. | Ummzy, LLC / 364 boxes/10 capsules per box | Class I | Terminated |
| D-0664-2021 | 03-30-2021 | Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680. | Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall. | Ummzy, LLC / 163 boxes/10 capsules per box | Class I | Terminated |
| D-0685-2021 | 03-29-2021 | Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC | Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall. | Nuri Trading LLC / N/A | Class I | Ongoing |
| D-0364-2021 | 03-29-2021 | Lite'n Foamy Healthcare Personnel Handwash (Chloroxylenol, 1.0%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26283 0 NDC: 64009-335-82 Package NDCs: 64009-335-85; 64009-335-82 | CGMP Deviations | Spartan Chemical Co Inc / 960 containers | Class II | Terminated |
| D-0686-2021 | 03-29-2021 | Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC | Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil, an FDA approved drug making this an unapproved drug for which the safety and efficacy has not been established and therefore subject to recall. | Nuri Trading LLC / N/A | Class I | Ongoing |
| D-0688-2021 | 03-29-2021 | 69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC | Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making it an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall. | Nuri Trading LLC / N/A | Class I | Ongoing |
| D-0687-2021 | 03-29-2021 | Thumbs Up 7 White 11K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC | Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil sildenafil, and vardenafil, FDA approved drugs making them an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall. | Nuri Trading LLC / N/A | Class I | Ongoing |
| D-0360-2021 | 03-29-2021 | foamyiQ Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 42.27 oz/1250 ml per foam pump cartridge, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26454 4 NDC: 64009-202-06 | CGMP Deviations | Spartan Chemical Co Inc / 26,328 cartridges | Class II | Terminated |
| D-0359-2021 | 03-29-2021 | Lite'n Foamy Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26288 5 SKU# 333806 NDC: 64009-331-82 | Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans | Spartan Chemical Co Inc / 19,044 containers | Class I | Terminated |
| D-0331-2021 | 03-29-2021 | Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC 52565-008-14. | Failed Stability Specifications: product did not meet viscosity results. | Teligent Pharma, Inc. / 62,040 tubes | Class III | Terminated |
| D-0361-2021 | 03-29-2021 | Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA.UPC 7 53727 26257 1 NDC: 64009-336-85 Package NDCs: 64009-336-85; 64009-336-90; 64009-336-91 | CGMP Deviations | Spartan Chemical Co Inc / 400 containers | Class II | Terminated |
| D-0363-2021 | 03-29-2021 | Lite'n Foamy Eucalyptus Mint Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53525 26287 8 NDC: 64009-332-72 Package NDCs: 64009-332-75; 64009-332-78; 64009-332-72 | CGMP Deviations | Spartan Chemical Co Inc / 1,200 cases | Class II | Terminated |
| D-0362-2021 | 03-29-2021 | Lite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26116 1 NDC: 64009-333-95 Package NDCs: 64009-333-95; 64009-333-98 | CGMP Deviations | Spartan Chemical Co Inc / 2,152 containers | Class II | Terminated |
| D-0332-2021 | 03-26-2021 | Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (when mixed) bottles (NDC 68180-402-02); and c) 100 mL (when mixed) bottles (NDC 68180-402-03); Rx only, Manufactured for: Lupin Pharmaceutical, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Mandideep 462 046, India. Package NDCs: 68180-401-03; 68180-401-01; 68180-401-02; 68180-402-01; 68180-402-03; 68180-402-02 | Superpotent Drug | Lupin Pharmaceuticals Inc. / a) 6,816 bottles; b) 3,960 bottles and c) 7,038 bottles | Class II | Terminated |
| D-0366-2021 | 03-26-2021 | Thumbs Up 7 Red 70K, 10 count blister pack cartons, Distributed by Ummzy LLC., Made in USA, UPC 6 17135 89467 3. | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil. | Antoto-K / 200 cartons | Class II | Terminated |
| D-0327-2021 | 03-25-2021 | Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080 | CGMP Deviaitons | Cosette Pharmaceuticals, Inc. / a) 30 mL: 7724 b) 60 mL: 8064 bottles | Class II | Terminated |
| D-0352-2021 | 03-25-2021 | Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards, distributed S&B Shopper LLC. Little Ferry, NJ UPC 7 18122 04073 5 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. | S & B Story LLC / N/A | Class II | Ongoing |
| D-0351-2021 | 03-25-2021 | PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA 90006 UPC 7 2817542189 4 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. | Namoo Enterprise LLC / N/A | Class II | Terminated |
| D-0325-2021 | 03-25-2021 | Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda HIghway, Halol-389 350 Gujarat, India, NDC 62756-142-02. Package NDCs: 62756-142-01; 62756-142-02; 62756-143-01 | Failed Moisture Limits: Out of specification for water content | SUN PHARMACEUTICAL INDUSTRIES INC / 2520 bottles | Class III | Terminated |
| D-0388-2021 | 03-24-2021 | Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil sheets in a box. Each box contains 10 capsules. | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil. | Bit & Bet LLC / 3894 ten-count boxes (38,940 capsules) | Class II | Terminated |
| D-0619-2021 | 03-22-2021 | TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Movo Mordisk Inc., Plainsboro, NJ 08536, NDC 0169-2660-90 (Pen), NDC 0169-2660-97 (Kit) Package NDCs: 0169-2660-15; 0169-2660-90; 0169-2660-97; 0169-2550-13; 0169-2550-90; 0169-2550-97; 0169-2662-11; 0169-2662-90 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0620-2021 | 03-22-2021 | TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2662-90 Package NDCs: 0169-2660-15; 0169-2660-90; 0169-2660-97; 0169-2550-13; 0169-2550-90; 0169-2550-97; 0169-2662-11; 0169-2662-90 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0621-2021 | 03-22-2021 | TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2550-90 (Pen), 0169-2550-97 (Kit) Package NDCs: 0169-2660-15; 0169-2660-90; 0169-2660-97; 0169-2550-13; 0169-2550-90; 0169-2550-97; 0169-2662-11; 0169-2662-90 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0617-2021 | 03-22-2021 | OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-4132-90 (Pen), NDC 0169-4132-97 (Kit) | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class II | Terminated |
| D-0615-2021 | 03-22-2021 | NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample. Not for Resale, Rx Only, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6339-90 (Pen), NDC 0169-6339-98 (Kit) Package NDCs: 0169-7501-11; 0169-7501-90; 0169-3303-12; 0169-3303-91; 0169-3303-90; 0169-6339-10; 0169-6339-90; 0169-6339-97; 0169-6339-98; 0169-6338-10; 0169-6338-90; 0169-6338-97; 0169-2001-90; 0169-2100-11; 0169-2101-12; 0169-2101-25 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0616-2021 | 03-22-2021 | NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark NDC 0169-7501-90 Package NDCs: 0169-7501-11; 0169-7501-90; 0169-3303-12; 0169-3303-91; 0169-3303-90; 0169-6339-10; 0169-6339-90; 0169-6339-97; 0169-6339-98; 0169-6338-10; 0169-6338-90; 0169-6338-97; 0169-2001-90; 0169-2100-11; 0169-2101-12; 0169-2101-25 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0614-2021 | 03-22-2021 | Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6438-90 (Pen), NDC 0169-6438-98 (Kit) | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0618-2021 | 03-22-2021 | Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. Not for Resale., Rx only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2800-90 (Pen), NDC 0169-2800-97 (Kit) Package NDCs: 0169-2800-15; 0169-2800-90; 0169-2800-97 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class II | Terminated |
| D-0623-2021 | 03-22-2021 | Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, SAMPLE, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2911-90 (Pen) NDC 0169-2911-97 (Kit) Package NDCs: 0169-2911-15; 0169-2911-90; 0169-2911-97 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0611-2021 | 03-22-2021 | Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk, Inc., Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-3204-90 (Pen), NDC 0169-3204-97 (Kit) Package NDCs: 0169-3201-11; 0169-3201-90; 0169-3204-15; 0169-3204-90; 0169-3204-97; 0169-3205-11; 0169-3205-15; 0169-3205-91; 0169-3205-95; 0169-3206-11; 0169-3206-15; 0169-3206-91; 0169-3206-95 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0613-2021 | 03-22-2021 | Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-3201-90 Package NDCs: 0169-3201-11; 0169-3201-90; 0169-3204-15; 0169-3204-90; 0169-3204-97; 0169-3205-11; 0169-3205-15; 0169-3205-91; 0169-3205-95; 0169-3206-11; 0169-3206-15; 0169-3206-91; 0169-3206-95 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0612-2021 | 03-22-2021 | Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-3205-91 Package NDCs: 0169-3201-11; 0169-3201-90; 0169-3204-15; 0169-3204-90; 0169-3204-97; 0169-3205-11; 0169-3205-15; 0169-3205-91; 0169-3205-95; 0169-3206-11; 0169-3206-15; 0169-3206-91; 0169-3206-95 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0622-2021 | 03-22-2021 | ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagesvaerd, Denmark NDC 0169-4060-90 (Pen), 0169-4060-99 (Kit) Package NDCs: 0169-4060-13; 0169-4060-12; 0169-4060-90; 0169-4060-97; 0169-4060-98; 0169-4060-99 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class II | Terminated |
| D-0329-2021 | 03-22-2021 | Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Daman (U.T.), India, NDC 33342-114-10 Package NDCs: 33342-114-07; 33342-114-51; 33342-114-12; 33342-114-10; 33342-115-07; 33342-115-51; 33342-115-12; 33342-115-10; 33342-116-07; 33342-116-51; 33342-116-12; 33342-116-10; 33342-117-07; 33342-117-51; 33342-117-12; 33342-117-10 | Failed Impurities/Degradation Specifications | Macleods Pharma Usa Inc / 8015 packs | Class III | Terminated |
| D-0349-2021 | 03-19-2021 | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400 | CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity. | CareFusion 213, LLC / 40,720,900 cartons | Class II | Terminated |
| D-0312-2021 | 03-19-2021 | Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-10 | Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer | Golden State Medical Supply Inc. / N/A | Class II | Terminated |
| D-0344-2021 | 03-19-2021 | BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415 Package NDCs: 54365-400-33 | Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity. | CareFusion 213, LLC / 1,434,000 cartons | Class I | Terminated |
| D-0345-2021 | 03-19-2021 | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400 | Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity. | CareFusion 213, LLC / 11,115,774 cartons | Class I | Terminated |
| D-0328-2021 | 03-19-2021 | Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5 | Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay | X-Gen Pharmaceuticals Inc. / 720 100-count (10x10 blister strips) | Class II | Terminated |
| D-0343-2021 | 03-19-2021 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400 Package NDCs: 54365-400-32 | Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity. | CareFusion 213, LLC / 952,100 cartons | Class I | Terminated |
| D-0348-2021 | 03-19-2021 | BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415 Package NDCs: 54365-400-33 | Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity. | CareFusion 213, LLC / 14,275,400 cartons | Class II | Terminated |
| D-0350-2021 | 03-19-2021 | ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415 | CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity. | CareFusion 213, LLC / 7,990,100 cartons | Class II | Terminated |
| D-0346-2021 | 03-19-2021 | ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415 | Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity. | CareFusion 213, LLC / 6,869,400 cartons | Class I | Terminated |
| D-0347-2021 | 03-19-2021 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400 Package NDCs: 54365-400-32 | Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity. | CareFusion 213, LLC / 24,969,700 cartons | Class II | Terminated |
| D-0330-2021 | 03-19-2021 | Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC: 69306-004-21, Relabeled by: Enovachem Pharmaceuticals 379 Van Ness Ave. Suite 1403-1406, Torrance, CA 90501, Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Source NDC: 59746-001-03, DocRx, Mobile, AL 36608 | Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card. | Asclemed USA Inc. dba Enovachem Pharmaceuticals / N/A | Class III | Ongoing |
| D-0323-2021 | 03-18-2021 | LCL-2-0191, 5 gallon carboys, Rx only, Manufactured for: LaCore Labs, LLC, by: Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411 | An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate. | Washington Homeopathic Products, Inc. / 300 liters | Class III | Terminated |
| D-0322-2021 | 03-18-2021 | Sp-4, 100 mL solution bottles, Rx only, Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411 | An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate. | Washington Homeopathic Products, Inc. / 114 bottles | Class III | Terminated |
| D-0321-2021 | 03-18-2021 | Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for: Natural Ophthalmics Inc. PO Box 1510 Dillon, CO 80435, NDC 58770-190-42 | An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate. | Washington Homeopathic Products, Inc. / 1,909 bottles | Class III | Terminated |
| D-0326-2021 | 03-17-2021 | Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30 Package NDCs: 62332-087-30; 62332-087-91; 62332-088-30; 62332-088-91; 62332-089-30; 62332-089-91; 1905005661 | Labeling: Label-mixup | Alembic Pharmaceuticals Limited / 12288 bottles | Class I | Terminated |
| D-0437-2021 | 03-15-2021 | IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO DROPS) Package NDCs: 59651-032-12; 59651-032-47 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 345 CARTONS | Class II | Terminated |
| D-0490-2021 | 03-15-2021 | AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 Package NDCs: 23155-287-10; 23155-287-01; 23155-288-01; 23155-288-10 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 122 bottles | Class II | Terminated |
| D-0436-2021 | 03-15-2021 | xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Package NDCs: 0310-6270-30; 0310-6270-95; 0310-6280-30; 0310-6280-95; 0310-6250-30; 0310-6250-95; 0310-6260-30; 0310-6260-60; 0310-6260-94; 0310-6260-95; 0310-6225-60; 0310-6225-94 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 378 bottles | Class II | Terminated |
| D-0575-2021 | 03-15-2021 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count bottles, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-3241-01 RX; TABLETS Package NDCs: 0093-3241-01; 0093-3242-01; 0093-3243-56 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 235 bottles | Class II | Terminated |
| D-0419-2021 | 03-15-2021 | Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 g Rx Only NDC 58914-301-80 Mfd. by: Pharbil Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany Distributed by: Aptalis Pharma US, Inc. Birmingham, AL 35242 Package NDCs: 58914-301-80; 58914-301-85 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 31 tubes | Class II | Terminated |
| D-0427-2021 | 03-15-2021 | Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC 60505-0813-1 Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Package NDCs: 60505-0813-1 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 38 bottles | Class II | Terminated |
| D-0458-2021 | 03-15-2021 | Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30 tablets Rx only NDC 0597-0295-88 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA Package NDCs: 0597-0280-36; 0597-0280-73; 0597-0280-90; 0597-0290-20; 0597-0290-59; 0597-0290-74; 0597-0295-61; 0597-0295-78; 0597-0295-88; 0597-0300-20; 0597-0300-45; 0597-0300-93 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 269 bottles | Class II | Terminated |
| D-0455-2021 | 03-15-2021 | Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg 30 tablets Rx only NDC 0597-0164-30 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA Package NDCs: 0597-0182-70; 0597-0182-07; 0597-0182-03; 0597-0182-30; 0597-0182-39; 0597-0182-90; 0597-0164-30; 0597-0164-39; 0597-0164-90; 0597-0164-70; 0597-0164-07 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 592 bottles | Class II | Terminated |
| D-0418-2021 | 03-15-2021 | Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg per capsule 30 capsules Rx Only NDC 0456-1214-30 Distributed by Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC. Package NDCs: 0456-1207-30; 0456-1214-11; 0456-1214-30; 0456-1214-63; 0456-1214-90; 0456-1221-30; 0456-1228-30; 0456-1228-90; 0456-1228-63; 0456-1228-11; 0456-1229-29; 0456-1229-04 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 659 bottles | Class II | Terminated |
| D-0403-2021 | 03-15-2021 | Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 Tablets For 28 Days Rx only NDC 0074-0038-28 Each carton contains 28 tablets in 4 weekly blister pack, Each weekly blister pack contains 7 tablets of elagolix 150 mg AbbVie Inc. North Chicago, IL 60064 Package NDCs: 0074-0038-28; 0074-0038-01; 0074-0038-07; 0074-0039-56; 0074-0039-01; 0074-0039-14 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 210 cartons | Class II | Terminated |
| D-0480-2021 | 03-15-2021 | Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhaler containing 1 Foil Strip of 30 Blisters Rx Only NDC 0173-0876-10 GlaxoSmithKline Research Triangle Park, NC 27709 Package NDCs: 0173-0888-10; 0173-0874-10; 0173-0874-14; 0173-0876-10; 0173-0876-14 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 353 inhalers | Class II | Terminated |
| D-0469-2021 | 03-15-2021 | PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES Package NDCs: 43598-291-90; 43598-291-05; 43598-291-79; 43598-291-66; 43598-291-78; 43598-292-90; 43598-292-05; 43598-292-79; 43598-292-66; 43598-292-78; 43598-293-90; 43598-293-05; 43598-293-79; 43598-293-66; 43598-293-78; 43598-294-90; 43598-294-05; 43598-294-79; 43598-294-66; 43598-294-78; 43598-295-90; 43598-295-05; 43598-295-79; 43598-295-66; 43598-295-78; 43598-296-90; 43598-296-05; 43598-296-79; 43598-296-66; 43598-296-78; 43598-297-90; 43598-297-05; 43598-297-79; 43598-297-66; 43598-297-78; 43598-298-90; 43598-298-05; 43598-298-79; 43598-298-66; 43598-298-78 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 6 CONTAINERS | Class II | Terminated |
| D-0417-2021 | 03-15-2021 | Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-30 Distributed by: Allergan USA, Inc. Irvine, CA 92612 Package NDCs: 0456-1203-30; 0456-1203-04; 0456-1203-07; 0456-1201-30; 0456-1201-04; 0456-1201-07; 0456-1202-30; 0456-1202-04; 0456-1202-07 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1529 bottles | Class II | Terminated |
| D-0566-2021 | 03-15-2021 | Tuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5 US Units, Rx Only Sanofi Pasteur Limited, NDC 49281-752-21 Package NDCs: 49281-752-78; 49281-752-21; 49281-752-98; 49281-752-22 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 406 vials | Class II | Terminated |
| D-0421-2021 | 03-15-2021 | Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-01 Manufactured by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 Distributed by: Alvogen, Inc. Parsippany, NJ 07054 U.S.A. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 15 bottles | Class II | Terminated |
| D-0474-2021 | 03-15-2021 | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML 473ML; NDC/UPC 71930-026-43; RX; SYRUP Package NDCs: 71930-026-18; 71930-026-43 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 73 carton | Class II | Terminated |
| D-0524-2021 | 03-15-2021 | Steglatro (ertugliflozin) tablets 15 mg 30 Tablets Rx only NDC 0006-5364-03 Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA Package NDCs: 0006-5363-03; 0006-5363-08; 0006-5363-09; 0006-5363-06; 0006-5363-07; 0006-5363-10; 0006-5364-03; 0006-5364-08; 0006-5364-09; 0006-5364-06; 0006-5364-07 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 215 bottles | Class II | Terminated |
| D-0529-2021 | 03-15-2021 | Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol 10 g net wt Rx Only NDC 0037-6822-10 Distributed by: Meda Pharmaceutical Inc. Somerset, New Jersey Package NDCs: 0037-6822-10 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 834 aerosol containers | Class II | Terminated |
| D-0543-2021 | 03-15-2021 | Benzoyl Peroxide 10% Acne Medication Wash Net Wt 5 oz (142 g) Distributed By Perrigo Allegan, MI 49010, NDC 45802-318-01 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 31 bottles | Class II | Terminated |
