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 August 08, 2025 and include a total of 16999 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0295-2021 | 02-19-2021 | Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5554-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel. | Noven Pharmaceuticals Inc / 786,900 patches | Class II | Terminated |
| D-0294-2021 | 02-19-2021 | Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5553-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel. | Noven Pharmaceuticals Inc / 551,670 patches | Class II | Terminated |
| D-0293-2021 | 02-19-2021 | Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel. | Noven Pharmaceuticals Inc / 473,280 patches | Class II | Terminated |
| D-0298-2021 | 02-19-2021 | Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-001-03 | Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card. | Jubilant Cadista Pharmaceuticals, Inc. / 635,400 cartons | Class III | Terminated |
| D-0291-2021 | 02-19-2021 | Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA Package NDCs: 55111-121-30; 55111-121-60; 55111-121-90; 55111-121-05; 55111-121-10; 55111-122-30; 55111-122-60; 55111-122-90; 55111-122-05; 55111-122-10; 55111-123-30; 55111-123-60; 55111-123-90; 55111-123-05; 55111-123-10 | Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities | Dr. Reddy's Laboratories, Inc. / 10,440 90-count and 224,710 500-count bottles | Class III | Terminated |
| D-0315-2021 | 02-18-2021 | Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 20mL Single-Dose Vials per pack NDC 68382-049-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India. Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. Package NDCs: 68382-048-01; 68382-048-10; 68382-049-01; 68382-049-10 | Crystallization: customer complaints for crystallization in finished product. | Zydus Pharmaceuticals (USA) Inc / 816 packs | Class I | Terminated |
| D-0316-2021 | 02-18-2021 | Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 10mL Single-Dose Vials per pack NDC 68382-048-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. Package NDCs: 68382-048-01; 68382-048-10; 68382-049-01; 68382-049-10 | Crystallization: customer complaints for crystallization in finished product. | Zydus Pharmaceuticals (USA) Inc / 1,638 packs | Class I | Terminated |
| D-0306-2021 | 02-17-2021 | Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Dolchester, VT 06448 NDC # 05446-1600-05 | Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions | Edge Pharma, LLC / 213 kits | Class III | Terminated |
| D-0288-2021 | 02-17-2021 | Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactured by Massachusetts General Hospital PET Center, Boston, MA NDC 76318-334-50 Package NDCs: 76318-334-50 | Lack of Assurance of Sterility | The General Hospital Corporation / 50 mL vial | Class II | Terminated |
| D-0287-2021 | 02-17-2021 | Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90); and b) For Institutional Use Only 30-count (3 x 10 unit-dose) tablets per carton (NDC 43598-344-31); Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540; Made in India. Package NDCs: 43598-344-30; 43598-344-90; 43598-344-10; 43598-344-31; 43598-345-30; 43598-345-90; 43598-345-05; 43598-345-31 | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / a) 1350 bottles; b) 147 cartons | Class II | Terminated |
| D-0310-2021 | 02-15-2021 | Adam's Secret Extra Strength 1500, 800 mg, 10 count blister packs, Distributed by KP Inc., Made in USA, UPC 6 09728 43462 5 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. | Adams.Secret.co / 218 boxes | Class I | Terminated |
| D-0311-2021 | 02-15-2021 | Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distributed by AS Inc., Made in USA, UPC 6 09728 43452 6. | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. | Adams.Secret.co / N/A | Class I | Terminated |
| D-0297-2021 | 02-15-2021 | Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Parsippany, NJ Vial NDC 0703-4502-01 (vial) NDC# 0703-4502-04 (tray) Package NDCs: 0703-4502-01; 0703-4502-04 | Chemical contamination; Unknown brown residue adhering to the inside of one vial. | Teva Pharmaceuticals USA / 9,452 cartons | Class II | Terminated |
| D-0276-2021 | 02-10-2021 | Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-5140-01. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 248,565 vials | Class II | Terminated |
| D-0275-2021 | 02-10-2021 | MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01), packaged in 25X1ML per tray (NDC 0703-0031-04), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 5,086 vials | Class II | Terminated |
| D-0282-2021 | 02-10-2021 | MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (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: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / N/A | Class II | Terminated |
| D-0281-2021 | 02-10-2021 | MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tray (NDC 0703-0051-04), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 5,378 vials | Class II | Terminated |
| D-0285-2021 | 02-10-2021 | Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA 92618, and b) Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, novaplus+, NDC 0703-5145-01. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 705,745 vials | Class II | Terminated |
| D-0279-2021 | 02-10-2021 | Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in 10 x 10 mL Vials per tray (NDC 0703-2914-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 33,6697 vials | Class II | Terminated |
| D-0277-2021 | 02-10-2021 | Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single-Use Vials per tray (NDC 0703-4502-04), Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618. Package NDCs: 0703-4502-01; 0703-4502-04 | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 29,357 vials | Class II | Terminated |
| D-0273-2021 | 02-10-2021 | Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01), packaged in 2X50ML per tray (NDC 0703-9258-09), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 26,373 vials | Class II | Terminated |
| D-0284-2021 | 02-10-2021 | MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0063-01. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 15,043 vials | Class II | Terminated |
| D-0278-2021 | 02-10-2021 | Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-5657-01. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 4,806 vials | Class II | Terminated |
| D-0272-2021 | 02-10-2021 | Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01), packaged in 10X1 mL Vials per Tray (NDC 0703-5051-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 2,577 vials | Class II | Terminated |
| D-0280-2021 | 02-10-2021 | Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1995-01. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 12,609 vials | Class II | Terminated |
| D-0274-2021 | 02-10-2021 | Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1985-01. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 12,629 vials | Class II | Terminated |
| D-0271-2021 | 02-10-2021 | Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), packaged in 10X20 ML Single Use Vials per tray (NDC 0703-5075-03); Rx only, TEVA Pharmaceuticals USA, INC., North Wales, PA 19454. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 50 vials | Class II | Terminated |
| D-0283-2021 | 02-10-2021 | MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0043-01. | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA / 6,710 vials | Class II | Terminated |
| D-0251-2021 | 02-05-2021 | Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion 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 62756-129-40 Package NDCs: 62756-129-40; 62756-129-44; 62756-129-45 | Failed Impurity/Degradation Specifications | SUN PHARMACEUTICAL INDUSTRIES INC / 20,475 vials | Class III | Terminated |
| D-0258-2021 | 02-04-2021 | Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-129-01 | Failed Dissolution Specifications | Wilshire Pharmaceuticals Inc / 2112 bottles | Class II | Terminated |
| D-0259-2021 | 02-04-2021 | Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-133-01 | Failed Dissolution Specifications | Wilshire Pharmaceuticals Inc / 35928 bottles | Class II | Terminated |
| D-0338-2021 | 02-02-2021 | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15 | Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. | Teligent Pharma, Inc. / 104,784 tubes | Class III | Terminated |
| D-0340-2021 | 02-02-2021 | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15 | Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. | Teligent Pharma, Inc. / N/A | Class III | Terminated |
| D-0261-2021 | 02-02-2021 | Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 1 mL Single Dose Syringes Rx Only, Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0795-4 UPC 360505079544 (carton) NDC 60505-0795-1 UPC (01)10360505079510 (label) | Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) | Apotex Corp. / 6670 cartons | Class I | Ongoing |
| D-0339-2021 | 02-02-2021 | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-51 | Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. | Teligent Pharma, Inc. / 79,416 tubes | Class III | Terminated |
| D-0262-2021 | 02-02-2021 | Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 0.8 mL Single Dose Syringes Rx Only,Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0796-4 UPC 360505079543 (carton) NDC 60505-0796-0 UPC (01)10360505079602 (label) | Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength) | Apotex Corp. / 6832 cartons | Class I | Ongoing |
| D-0319-2021 | 02-01-2021 | Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076-2199 Distributed in Canada by Kimberly-Clark Inc., Mississauga, Ontario L5B 3Y5 UPC 0 36000 91592 1 | Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled as Moisturizing Foam Hand Sanitizer | Kimberly-Clark Corporation / 2,982 cases | Class II | Terminated |
| D-0260-2021 | 01-29-2021 | Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01. | Failed Dissolution Specifications | Akebia Therapeutics dba Keryx Biopharmaceutials, Inc / 17,664 bottles | Class III | Terminated |
| D-0250-2021 | 01-28-2021 | Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India NDC 16729-472-08 (Vial NDC 16729-472-30) Package NDCs: 16729-471-08; 16729-472-08; 16729-473-03; 16729-474-03; 16729-474-05; 16729-472-30 | Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials | Accord Healthcare, Inc. / 502 cartons | Class III | Terminated |
| D-0286-2021 | 01-27-2021 | Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 x 5 mL Single-Dose Vials per carton (NDC 71288-712-06), Rx only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL 60631. Package NDCs: 71288-712-05; 71288-712-06; 71288-714-10; 71288-714-11; 71288-713-20; 71288-713-21 | Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium | Meitheal Pharmaceuticals Inc / 34,860 vials | Class I | Terminated |
| D-0304-2021 | 01-27-2021 | Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA, NDC 63629-1067-01 | Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets. | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals / 12 bottles | Class II | Ongoing |
| D-0303-2021 | 01-27-2021 | Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-count bottles (NDC 63629-1064-03), Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA | Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets. | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals / 35 bottles | Class I | Ongoing |
| D-0249-2021 | 01-25-2021 | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01 Package NDCs: 29033-055-01; 29033-055-05; 29033-055-10; 29033-056-01; 29033-056-10 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. | Nostrum Laboratories Inc / 7071 bottles | Class II | Ongoing |
| D-0264-2021 | 01-22-2021 | Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68 Package NDCs: 67877-544-88; 67877-544-68; 67877-545-88; 67877-545-68 | CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit. | Ascend Laboratories LLC / 23,436 200 mL bottles | Class II | Terminated |
| D-0263-2021 | 01-22-2021 | Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88 Package NDCs: 67877-544-88; 67877-544-68; 67877-545-88; 67877-545-68 | CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit. | Ascend Laboratories LLC / 14,205 100 mL bottles | Class II | Terminated |
| D-0252-2021 | 01-21-2021 | Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic ointment jar, Rx Only, Stanley Specialty Pharmacy 3120 Latrobe Dr. Suite 200 Charlotte, NC 28211 | Superpotent Drug. Lidocaine higher concentration than listed | Stanley Specialty Pharmacy Compounding and Wellness Center / 4400 grams (44 jars) | Class II | Terminated |
| D-0247-2021 | 01-21-2021 | Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Maharashtra, India. NDC: 68180-678-01 Package NDCs: 68180-678-01 | Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point. | Lupin Pharmaceuticals Inc. / 46,479 bottles | Class III | Terminated |
| D-0290-2021 | 01-20-2021 | Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India, NDC 65862-860-99 Package NDCs: 65862-859-30; 65862-859-01; 65862-859-05; 65862-859-99; 65862-859-10; 65862-859-78; 65862-860-30; 65862-860-01; 65862-860-05; 65862-860-99; 65862-860-10; 65862-860-78 | Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg. | Aurobindo Pharma USA Inc. / 1296 bottles | Class II | Terminated |
| D-1124-2022 | 01-15-2021 | Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 67877-0573-05 | Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules. | Calvin Scott & Company, Inc. / 10 bottles | Class I | Terminated |
| D-1123-2022 | 01-15-2021 | Benzphetamine tablets, 50mg, CIII, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 10702-0040-50 | Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules. | Calvin Scott & Company, Inc. / 13 bottles | Class III | Terminated |
| D-0242-2021 | 01-11-2021 | Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial Distributed by: Sun Pharma Ind. Inc, NJ 08512 Manufactured by: Sun Pharma Ind. Ltd., India NDC 62756-015-40 Package NDCs: 62756-017-40; 62756-015-40; 62756-016-40 | Incorrect Labeling: Incorrect lot number on secondary packaging | SUN PHARMACEUTICAL INDUSTRIES INC / 36,275 cartons | Class III | Terminated |
| D-0246-2021 | 01-08-2021 | Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 NDC 51672-4001-1 Package NDCs: 51672-4001-6; 51672-4001-5; 51672-4001-1; 51672-4001-2; 51672-4002-6; 51672-4002-4; 51672-4002-5; 51672-4002-1; 51672-4002-2; 51672-4003-6; 51672-4003-5; 51672-4003-1; 51672-4003-2; 51672-4004-6; 51672-4004-5; 51672-4004-1; 51672-4004-2 | CGMP deviations. | Taro Pharmaceuticals U.S.A., Inc. / 44,256 bottles | Class II | Terminated |
| D-0244-2021 | 01-07-2021 | Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA NDC 68682-170-30 | Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D. | Bausch Health Companies, Inc. / 14,089 bottles | Class III | Terminated |
| D-0243-2021 | 01-07-2021 | Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05 | Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D. | Bausch Health Companies, Inc. / 895 bottles | Class III | Terminated |
| D-0232-2021 | 01-07-2021 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11 | Failed Dissolution Specifications | American Health Packaging / 1948 cartons | Class II | Terminated |
| D-0257-2021 | 01-06-2021 | Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ Fabricado por: De La Cruz Products, A Division of DLC Laboratories, Inc. Paramount, CA 9023 USA; UPC 024286150426 | Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product. | DLC Laboratories, Inc / 86,297 jars | Class II | Terminated |
| D-0227-2021 | 01-04-2021 | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01 Package NDCs: 29033-055-01; 29033-055-05; 29033-055-10; 29033-056-01; 29033-056-10 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Nostrum Laboratories Inc / 6958 Bottles | Class II | Ongoing |
| D-0228-2021 | 01-01-2021 | Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit Dose Cups (100-pack case) NDC 68094-028-62, Rx only, Precision Dose, Inc., South Beloit, IL 61080. | cGMP deviations: The firm was notified of the manufacturer's expanded recall. | Precision Dose Inc. / 1,107,510 unit dose cups | Class II | Terminated |
| D-0233-2021 | 12-30-2020 | Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie company Madison, NJ 07940 UPC 3 00236 63410 0, NDC 0023-6634-10. Package NDCs: 0023-6634-10; 0023-6634-01 | Labeling: Missing instructions for use insert | Allergan, PLC. / 100,634 bottles | Class II | Terminated |
| D-0248-2021 | 12-30-2020 | Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Made in India NDC 55150-307-01 Package NDCs: 55150-307-01; 55150-307-24 | Discoloration and failed pH specifications | AuroMedics Pharma LLC / 3094 cartons | Class II | Terminated |
| D-0221-2021 | 12-28-2020 | Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16 | Defective container: Customer complaints for oral solution leaking from bottles. | Akorn, Inc. / 22,248 bottles | Class II | Terminated |
| D-0222-2021 | 12-28-2020 | Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL | cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions | Sunstar Americas, Inc. / a) 1,021,914 bottles; b) 255,552 bottles | Class II | Ongoing |
| D-0245-2021 | 12-23-2020 | Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047. Package NDCs: 63323-161-00; 63323-161-01; 63323-162-11; 63323-162-51; 63323-162-00; 63323-162-01; 63323-162-03; 63323-162-02 | Presence of Particulate Matter - found in reserve sample vials at the firm. | Fresenius Kabi USA, LLC / 945,425 vials | Class I | Terminated |
| D-0231-2021 | 12-23-2020 | Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354-450(40 unit dose cups) Case NDC 64950-354-55 (50 unit dose cups) Package NDCs: 64950-353-03; 64950-353-01; 64950-353-91; 64950-353-51; 64950-353-02; 64950-353-92; 64950-353-52; 64950-354-10; 64950-354-50; 64950-354-05; 64950-354-55; 64950-354-45 | Presence of Foreign Substance: Particulate matter was found in multiple lots of product. | Genus Lifesciences Inc. / 1,171,550 cups | Class III | Terminated |
| D-0240-2021 | 12-23-2020 | IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384. Labeled as a) SAFE-GUARD Products International, b) Safe-WAY JEVCO Wash-Free Hand Sanitizer, c) TRACTION CAPITAL, d) United States Census 2020. UPC 8 19845 00598 5 | CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol. | Shane Erickson Inc / 42,157 bottles | Class II | Terminated |
| D-0241-2021 | 12-23-2020 | IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 10.1 fl. oz. (300 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384. Labeled as Thrifty White Pharmacy Wash-Free Hand Sanitizer. UPC 8 19845 00599 2 | CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol. | Shane Erickson Inc / 29,376 bottles | Class II | Terminated |
| D-0239-2021 | 12-23-2020 | IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 1.7 fl. oz. (50 ml) bottles, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384, Made in China, ALSO distributed with Custom front labels as follows a) Sadie G. Mays Health & Rehabilitation Center, b) Pacers logo, c) northwood CHURCH, d) ROGERTHEROOFER.com and e) SoFi Stadium Wash-Free Hand Sanitizer. UPC 8 19845 00597 8 | CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol. | Shane Erickson Inc / 36,505 bottles | Class II | Terminated |
| D-0307-2021 | 12-22-2020 | Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge Pharma LLC 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01 | Labeling: Incorrect or Missing Lot and/or Exp Date | Edge Pharma, LLC / 60 syringes | Class III | Terminated |
| D-0180-2021 | 12-22-2020 | NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Package NDCs: 64380-720-06; 64380-720-01; 64380-721-06; 64380-721-01; 64380-722-01; 64380-722-06 | Failed Moisture Limits | Strides Pharma Inc. / 960 bottles | Class III | Terminated |
| D-0176-2021 | 12-21-2020 | Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. for: Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc., NDC 67919-030-01 Package NDCs: 67919-030-01 | Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches. | Merck Sharp & Dohme / 106,503 vials | Class II | Terminated |
| D-0224-2021 | 12-18-2020 | Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01 | Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A | KVK-Tech, Inc. / 528 bottles | Class III | Terminated |
| D-0179-2021 | 12-17-2020 | Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68 Package NDCs: 67877-544-88; 67877-544-68; 67877-545-88; 67877-545-68 | Failed Impurity/Degradation Specifications | Ascend Laboratories LLC / 9,524 bottles | Class II | Terminated |
| D-0181-2021 | 12-17-2020 | Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-527-34 Package NDCs: 69097-527-34 | Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline | CIPLA / 284,610 packets | Class II | Terminated |
| D-0182-2021 | 12-17-2020 | Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-528-34 Package NDCs: 69097-528-34; 69097-529-34 | Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline | CIPLA / 289350 packets | Class II | Terminated |
| D-0269-2021 | 12-17-2020 | ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (40mL) bottle, 270 measured sprays, Distributed by Ndal Laboratories, 449 Alvarado St., Monterey, CA 93940 (bottle); NDAL MFG Inc., 80 Garden Court, Suite 100, Monterey, CA 93940 (carton); UPC 8 58631 00212 8. the Alvarado St. is for the bottle by putting "(bottle); NDAL MFG Inc., 80 Garden Court, Suite 100, Monterey, CA 93940 (carton); UPC 8 58631 00212 8." (according to the label) | Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast | NDAL Mfg Inc. / 4265 bottles | Class I | Ongoing |
| D-0177-2021 | 12-17-2020 | Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ - 07852 (844)446-6979 | Lack of assurance of sterility: 13 vials were discovered to have faulty crimps. | Imprimis NJOF, LLC / 6520 vials | Class II | Terminated |
| D-0178-2021 | 12-17-2020 | Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88 Package NDCs: 67877-544-88; 67877-544-68; 67877-545-88; 67877-545-68 | Failed Impurity/Degradation Specifications | Ascend Laboratories LLC / 29,317 bottles | Class II | Terminated |
| D-0184-2021 | 12-17-2020 | Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02 Package NDCs: 63323-161-00; 63323-161-01; 63323-162-11; 63323-162-51; 63323-162-00; 63323-162-01; 63323-162-03; 63323-162-02 | Presence of Particulate Matter - found in reserve sample vials at the firm. | Fresenius Kabi USA, LLC / 490,633 vials | Class II | Terminated |
| D-0183-2021 | 12-17-2020 | Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 NDC 69097-529-34 Package NDCs: 69097-528-34; 69097-529-34 | Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline | CIPLA / 6,491 packets | Class II | Terminated |
| D-0212-2021 | 12-17-2020 | SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095, barcode 70004090809 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 5067 syringes | Class II | Terminated |
| D-0192-2021 | 12-17-2020 | fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals,755 Rainbow Rd., Windsor, CT, 06095, barcode 70004023122 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 996 syringes | Class II | Terminated |
| D-0206-2021 | 12-17-2020 | Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR, 72205, barcode 70004085012 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 7,940 syringes | Class II | Terminated |
| D-0211-2021 | 12-17-2020 | Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 and b) 5 mL Single Dose Syringe White Label (barcode 70004085028), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 13,096 syringes | Class II | Terminated |
| D-0204-2021 | 12-17-2020 | PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081012 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 23,029 syringes | Class II | Terminated |
| D-0186-2021 | 12-17-2020 | Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004004006 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 1,930 syringes | Class II | Terminated |
| D-0193-2021 | 12-17-2020 | fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004020016 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 2,834 syringes | Class II | Terminated |
| D-0216-2021 | 12-17-2020 | PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 3152 syringes | Class II | Terminated |
| D-0191-2021 | 12-17-2020 | fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 1,774 syringes | Class II | Terminated |
| D-0214-2021 | 12-17-2020 | fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 6710 syringes | Class II | Terminated |
| D-0203-2021 | 12-17-2020 | neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004075009 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 390 syringes | Class II | Terminated |
| D-0215-2021 | 12-17-2020 | HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004030022 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 428 syringes | Class II | Terminated |
| D-0198-2021 | 12-17-2020 | labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004070028 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 9,057 syringes | Class II | Terminated |
| D-0194-2021 | 12-17-2020 | Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 1,614 syringes | Class II | Terminated |
| D-0187-2021 | 12-17-2020 | Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local Anesthetic Use, 5 mL Single Dose Syringe, Rx Only SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072509 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 3,793 syringes | Class II | Terminated |
| D-0196-2021 | 12-17-2020 | HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 1,056 syringes | Class II | Terminated |
| D-0208-2021 | 12-17-2020 | SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090812 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 3,239 syringes | Class II | Terminated |
| D-0188-2021 | 12-17-2020 | ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004060509 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 1,879 syringes | Class II | Terminated |
| D-0199-2021 | 12-17-2020 | Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072012 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 1,880 syringes | Class II | Terminated |
| D-0217-2021 | 12-17-2020 | Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043009 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 9942 syringes | Class II | Terminated |
| D-0190-2021 | 12-17-2020 | Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004062012 | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit | SCA Pharmaceuticals / 952 syringes | Class II | Terminated |
