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 September 05, 2025 and include a total of 17050 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0791-2016 | 02-12-2016 | Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9996-35 | Lack of Assurance of Sterility | Walter's Pharmacy / 2 bottles | Class II | Terminated |
| D-0786-2016 | 02-12-2016 | Cefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9999-69 / 89999-9001-04 | Lack of Assurance of Sterility | Walter's Pharmacy / 4 bottles | Class II | Terminated |
| D-0811-2016 | 02-12-2016 | Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911) per carton (NDC 50268-569-13, barcode 5026856913), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. | Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650. | Apace KY LLC / 291 cartons | Class III | Terminated |
| D-0797-2016 | 02-12-2016 | Vancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9991-54 | Lack of Assurance of Sterility | Walter's Pharmacy / 1 bottle | Class II | Terminated |
| D-0794-2016 | 02-12-2016 | Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9018-33 | Lack of Assurance of Sterility | Walter's Pharmacy / 2 bottles | Class II | Terminated |
| D-0793-2016 | 02-12-2016 | Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N 17th St Allentown, PA 610-435-4706, NDC 99999-9019-09 | Lack of Assurance of Sterility | Walter's Pharmacy / 22 bottles | Class II | Terminated |
| D-0840-2016 | 02-12-2016 | Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93 | Failed Dissolution Specifications; three month stability time point. | Mylan Pharmaceuticals Inc. / 2928 bottles | Class II | Terminated |
| D-0798-2016 | 02-12-2016 | Tobramycin 14 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9996-60 | Lack of Assurance of Sterility | Walter's Pharmacy / 1 bottle | Class II | Terminated |
| D-0792-2016 | 02-12-2016 | Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9003-78 | Lack of Assurance of Sterility | Walter's Pharmacy / 4 bottles | Class II | Terminated |
| D-0795-2016 | 02-12-2016 | Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47 | Lack of Assurance of Sterility | Walter's Pharmacy / 1 bottle | Class II | Terminated |
| D-0734-2016 | 02-11-2016 | sulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp conditioner, 2%, packaged in a) 2 OZ (57g) jar (UPC 0 75610 43510 8), and b) 4 OZ (113g) jar (UPC 0 75610 43610 5), 1 dozen jars per case, J. Strickland & Co., PO Box 1637, Olive Branch, MS 38654 | Subpotent Drug: failed at the 3 and 6 month stability time points. | J. Strickland and Co / 1170 cases | Class III | Terminated |
| D-0871-2016 | 02-11-2016 | Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78. | Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj. | Pharmakon Pharmaceuticals / 75 Syringes | Class I | Terminated |
| D-0735-2016 | 02-11-2016 | Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3 41616 63868 4. | Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point. | Sun Pharma Global Fze / 381,120 cartons | Class II | Terminated |
| D-0800-2016 | 02-10-2016 | Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (237 mL), Distributed by Pfizer, Madison, NJ 07940, NDC 0031-8736-18 | Labeling: Label Mix-Up | Pfizer Inc / 63,636 plastic bottles | Class III | Terminated |
| D-0666-2016 | 02-09-2016 | TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Use Vials, packaged in 60-count Single-Use Vials per carton, Manufactured for: Alcon Laboratories, Inc., Fort Work, TX 76134, Barcode 90016741106, UPC 3 00650 41636 8. | Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials. | Alcon Research, Ltd. / 12,648 cartons | Class II | Terminated |
| D-0726-2016 | 02-08-2016 | Medicated Better Braids, La Laque (salicylic acid) Spray, 2%,12 Fl. OZ. (355 ml.) bottle, Distributed by Keystone Laboratories, Memphis, TN 38101-2026, UPC 0 70596 00422 5. | Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus aureus test result. | Keystone Laboratories Inc / 134 cases of 12 bottles/case | Class II | Terminated |
| D-0774-2016 | 02-05-2016 | Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt Valley, MD 21031, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7656-56. | Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing. | Teva Pharmaceuticals USA / 30,891 Bottles | Class II | Terminated |
| D-0776-2016 | 02-05-2016 | Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tanks, Rx Only. Medical Park Homecare, 139 SE Katherine Ave., Bartlesville, OK 74006. | CGMP Deviations: Cylinders filled using out of date gauges. | Medical Park Homecare, Inc / a) 289 M6-Tank Cylinders, b) 49 D-Tank Cylinders, c) 743 E-Tank Cylinders. | Class III | Terminated |
| D-0731-201 | 02-05-2016 | 0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product code 2F7123, NDC 0338-0048-03 Package NDCs: 0338-0048-02; 0338-0048-03; 0338-0048-04; 0338-0048-05 | PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect. | Baxter Healthcare Corp. / 257,364 bottles | Class II | Terminated |
| D-0781-2016 | 02-05-2016 | Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only. Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. Manufactured by: Forest Laboratories, Ireland Limited, Dublin 17 Ireland. Product of Spain. NDC: 0310-0800-60. | Defective Delivery System: Some units have actuation counters set to a number other than 60. | AstraZeneca Pharmaceuticals LP / 148,331 Inhalers | Class II | Terminated |
| D-0762-2016 | 02-04-2016 | Morphine Sulfate 20 mg/ml, vol. 42 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0756-2016 | 02-04-2016 | Hydromorphone HCL 1 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 2 syringes | Class II | Terminated |
| D-0745-2016 | 02-04-2016 | Morphine Sulfate 50 mg/ml/Bupivacaine HCL 24 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0742-2016 | 02-04-2016 | Sufentanil Cit 1000 mcg/ml/Baclofen 300 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0747-2016 | 02-04-2016 | Morphine Sulfate 10 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0750-2016 | 02-04-2016 | Hydromorphone HCL 25 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0759-2016 | 02-04-2016 | Morphine Sulfate 11 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0739-2016 | 02-04-2016 | Morphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml/, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0751-2016 | 02-04-2016 | Hydromorphone HCL 10 mg/ml/Fentanyl Citrate 0.15 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0737-2016 | 02-04-2016 | Baclofen 5000 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0757-2016 | 02-04-2016 | Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0752-2016 | 02-04-2016 | Hydromorphone HCL 10 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0753-2016 | 02-04-2016 | Hydromorphone HCL 2 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0765-2016 | 02-04-2016 | Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0736-2016 | 02-04-2016 | Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0755-2016 | 02-04-2016 | Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/ Clonidine HCL 450 mcg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0764-2016 | 02-04-2016 | Hydromorphone HCL 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0761-2016 | 02-04-2016 | Sufentanil Cit 200 mcg/ml/Clonidine HCL 1600 mcg/ml, vol. 42 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0738-2016 | 02-04-2016 | Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0760-2016 | 02-04-2016 | Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 11.2 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0758-2016 | 02-04-2016 | Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0741-2016 | 02-04-2016 | Morphine Sulfate 9 mg/ml/Sufentanil Cit 180 mcg/ml/Bupivacaine HCL 33 mg/ml, vol. 20 ml vial, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 vial | Class II | Terminated |
| D-0743-2016 | 02-04-2016 | Morphine Sulfate 0.6 mg/ml, vol. 200 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 2 syringes | Class II | Terminated |
| D-0740-2016 | 02-04-2016 | Hydromorphone 12 mg/ml/Baclofen 450 mcg/ml, vol. 20 ml, syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0754-2016 | 02-04-2016 | Morphine Sulfate 1.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 2 syringes | Class II | Terminated |
| D-0763-2016 | 02-04-2016 | Morphine Sulfate 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0749-2016 | 02-04-2016 | Hydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 mg/ml, vol. 20 ml syringe Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0744-2016 | 02-04-2016 | Morphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0746-2016 | 02-04-2016 | Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 30 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0748-2016 | 02-04-2016 | Baclofen 2000 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Lack of Assurance of Sterility | Hartley Medical Center Pharmacy, Incorporated / 1 syringe | Class II | Terminated |
| D-0728-2016 | 02-02-2016 | Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection, Rx only, Isomeric Pharmacy Solutions, 2401 Foothill Dr., Salt Lake City, UT 84109 | Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use Beyond " date or BUD (Before Use Date) that may be longer than intended. | Isomeric Pharmacy Solution, LLC / 114 vials | Class III | Terminated |
| D-0727-2016 | 02-02-2016 | Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0. | Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017". | Hospira Inc. / 10,778 bags | Class III | Ongoing |
| D-0650-2016 | 01-28-2016 | Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21 | Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 868 unit cartons (86,800 tablets) | Class III | Terminated |
| D-0768-2016 | 01-27-2016 | Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-324-77 | Failed Impurities/Degradation Specifications | Golden State Medical Supply Inc. / 74 100-count packages (7,400 tablets) | Class III | Terminated |
| D-0767-2016 | 01-27-2016 | Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-323-77 | Failed Impurities/Degradation Specifications | Golden State Medical Supply Inc. / 222 100-count packages (22,000 tablets) | Class III | Terminated |
| D-0770-2016 | 01-27-2016 | Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-326-77 | Failed Impurities/Degradation Specifications | Golden State Medical Supply Inc. / 168 100-count packages (16,800 tablets) | Class III | Terminated |
| D-0769-2016 | 01-27-2016 | Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-325-77 | Failed Impurities/Degradation Specifications | Golden State Medical Supply Inc. / 172 100-count packages (17,200 tablets) | Class III | Terminated |
| D-0665-2016 | 01-27-2016 | Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches, RX Only, Manufactured for Bonita Pharmaceuticals LLC 6380 Commerce Drive Westland, MI 48185-9120, USA NDC 53598-0012-15 | Marketed without an approved NDA/ANDA | Bonita Pharmaceuticals, LLC / 3,308 boxes | Class II | Terminated |
| D-0660-2016 | 01-26-2016 | Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus, Ohio 43217, NDC 68084-877-25(carton), NDC 68084-877-95(individual dose) | Failed Impurities/Degradation Specifications; 9 month stability (manufacturer) | Amerisource Health Services / 716 cartons | Class III | Terminated |
| D-1435-2016 | 01-26-2016 | Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560; | Failed Dissolution Specification: Out of specification dissolution results when testing product stability. | Apotex Scientific, Inc / 107,880 (60 ct bottle) | Class III | Terminated |
| D-1437-2016 | 01-26-2016 | Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638. | Failed Dissolution Specification: Out of specification dissolution results when testing product stability. | Apotex Scientific, Inc / 750,273 (30 ct) bottles | Class III | Terminated |
| D-1436-2016 | 01-26-2016 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737; | Failed Dissolution Specification: Out of specification dissolution results when testing product stability. | Apotex Scientific, Inc / 605,989 (30 ct) bottles | Class III | Terminated |
| D-0862-2016 | 01-21-2016 | 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18. Package NDCs: 0338-0553-11; 0338-0553-18 | Presence of Particulate Matter: identified as cardboard. | Baxter Healthcare Corp. / 273,520 bags | Class I | Terminated |
| D-0863-2016 | 01-21-2016 | Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48. Package NDCs: 0338-1055-48 | Presence of Particulate Matter: identified as a cloth fiber. | Baxter Healthcare Corp. / 334,560 bags | Class I | Terminated |
| D-0864-2016 | 01-21-2016 | CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Injection with Electrolytes, 2000 mL CLARITY Dual Chamber Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B7721, NDC 0338-1123-04. Package NDCs: 0338-1142-03; 0338-1144-03; 0338-1113-04; 0338-1145-03; 0338-1115-04; 0338-1147-03; 0338-1123-04; 0338-1125-04; 0338-1148-03; 0338-0202-01; 0338-0202-06; 0338-0206-01; 0338-0206-04; 0338-0210-01; 0338-0210-06; 0338-0214-01; 0338-0214-04; 0338-7020-01; 0338-7020-06; 0338-7022-01; 0338-7022-06; 0338-7024-01; 0338-7024-04; 0338-7026-01; 0338-7026-06; 0338-7028-01; 0338-7028-04; 0338-7030-01; 0338-7030-06; 0338-7032-01; 0338-7032-04; 0338-7034-01; 0338-7034-06; 0338-7036-01; 0338-7036-04 | Presence of Particulate Matter: identified as dried skin. | Baxter Healthcare Corp. / 7,436 bags | Class I | Terminated |
| D-0861-2016 | 01-21-2016 | 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18. Package NDCs: 0338-0553-11; 0338-0553-18 | Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility. | Baxter Healthcare Corp. / 282,080 bags | Class II | Terminated |
| D-0652-2016 | 01-18-2016 | Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157 | Labeling: label error on declared strength. | Perrigo Company PLC / 918 units | Class II | Terminated |
| D-0645-2016 | 01-18-2016 | Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-735-05), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. Package NDCs: 24208-735-01; 24208-735-06; 24208-735-05 | Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. | Bausch & Lomb, Inc. / a) 905,956 Bottles, b) 191,375 Bottles | Class III | Terminated |
| D-0646-2016 | 01-18-2016 | Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64. Package NDCs: 24208-590-64; 24208-585-59; 24208-585-64 | Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. | Bausch & Lomb, Inc. / 119,393 Bottles | Class III | Terminated |
| D-0651-2016 | 01-18-2016 | Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058. | Labeling: label error on declared strength. | Perrigo Company PLC / 948 units | Class II | Terminated |
| D-0647-2016 | 01-18-2016 | Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. Package NDCs: 24208-590-64; 24208-585-59; 24208-585-64 | Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. | Bausch & Lomb, Inc. / a) 416,441 Bottles b) 674,177 Bottles | Class III | Terminated |
| D-0610-2016 | 01-18-2016 | Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled UPC (01) 003 68084 482 11 3, carton labeled NDC 68084-482-01, UPC (01) 0 03 68084 482 01 4; Rx only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. | Failed Dissolution Specifications: Unexplained low out of specification results for dissolution. | Amerisource Health Services / 3,888 cartons | Class II | Terminated |
| D-0714-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 9/1 mg/10 mcg/mL, 10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 10 ml | Class II | Terminated |
| D-0700-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 25/0.83 mg/10 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 10 ml | Class II | Terminated |
| D-0693-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 12/1 mg/10 mcg/mL 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 10 ml | Class II | Terminated |
| D-0687-2016 | 01-15-2016 | methylcobalamine 4 mg/mL, 5 mL and 30 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 35 ml | Class II | Terminated |
| D-0706-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 30/1 mg/20 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 10 ml | Class II | Terminated |
| D-0678-2016 | 01-15-2016 | Estradiol cypionate/Test cyprionate; 2 mg/50 mg/ml, unit size 5 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 5 ml | Class II | Terminated |
| D-0681-2016 | 01-15-2016 | Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 90 ml | Class II | Terminated |
| D-0703-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 25/1 mg/30 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 10 ml | Class II | Terminated |
| D-0702-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 25/1.5 mg/15 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 10 ml | Class II | Terminated |
| D-0689-2016 | 01-15-2016 | papaverine prostaglandin 30 mg/20 mcg/mL, 10 mL unit size; refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / | Class II | Terminated |
| D-0682-2016 | 01-15-2016 | hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 38 ml | Class II | Terminated |
| D-0705-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 30/1 mg/10 mcg/mL; 5 mL, 7 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 62 ml | Class II | Terminated |
| D-0698-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 22.5/0.83 mg/8.3 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 5 ml | Class II | Terminated |
| D-0676-2016 | 01-15-2016 | Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 7200 mL | Class II | Terminated |
| D-0688-2016 | 01-15-2016 | papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 5 ml | Class II | Terminated |
| D-0711-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 35/1.5 mg/50 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 5 ml | Class II | Terminated |
| D-0707-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 30/2 mg/20 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 40 ml | Class II | Terminated |
| D-0684-2016 | 01-15-2016 | Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 10 ml | Class II | Terminated |
| D-0708-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 30/2 mg/25 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 5 ml | Class II | Terminated |
| D-0718-2016 | 01-15-2016 | papaverine phent, 25 mg/0.833 mg/mL, 20 mL unit size Refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 20 ml | Class II | Terminated |
| D-0683-2016 | 01-15-2016 | hydroxyprogesterone w/ pres; 1 mg/mL, 20 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 20 ml | Class II | Terminated |
| D-0701-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 25/0.83 mg/20 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 25 ml | Class II | Terminated |
| D-0716-2016 | 01-15-2016 | testosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 36 ml | Class II | Terminated |
| D-0715-2016 | 01-15-2016 | progesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, room temperature, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 10 ml | Class II | Terminated |
| D-0680-2016 | 01-15-2016 | Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 6 ml | Class II | Terminated |
| D-0697-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 18/0.6 mg/6 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 10 ml | Class II | Terminated |
| D-0686-2016 | 01-15-2016 | methylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 41 ml | Class II | Terminated |
| D-0690-2016 | 01-15-2016 | papaverine phentolamine 30 mg/1mg/mL, 5 mL and 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 30 ml | Class II | Terminated |
