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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-0699-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 22.5/0.83 mg/15 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-0713-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 35/2 mg/40 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-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-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-0685-2016 | 01-15-2016 | methylcobalamine 10 mg/mL, 10 mL and 12 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. / 22 ml | Class II | Terminated |
| D-0692-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 12/0.83 mg/10 mcg/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. / 10 ml | Class II | Terminated |
| D-0677-2016 | 01-15-2016 | calcium elemental, 3 mg/10 mL, 200 mL unit: 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. / 200 ml | Class II | Terminated |
| D-0717-2016 | 01-15-2016 | testosterone cypionate, 100 mg/mL, 10 mL unit size, 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-0691-2016 | 01-15-2016 | papaverine phentolamine, 35 mg/2.5 mg/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-0694-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 12/1 mg/9 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-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-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-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-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-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-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-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-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 |
| 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-0709-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 30 mg/0.25 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-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-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-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-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-0775-2016 | 01-15-2016 | Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For: Virtus Pharmaceuticals, Tampa, FL | Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate). | Virtus Pharmaceuticals, Llc / 1,139 bottles total | Class III | Terminated |
| D-0704-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 30/1.5 mg/40 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-0696-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 17.16/0.57 mg/19.45 mcg/mL; 5 mLunit 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-0679-2016 | 01-15-2016 | Folic Acid, 5 mg/mL, 30 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 |
| D-0712-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 35/2.5 mg/1 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-0695-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 12/1 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-0710-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 35/1.2 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. / 10 ml | Class II | Terminated |
| D-0908-2016 | 01-15-2016 | Licorice Coughing Liquid (guaifenesin), 5%, 3.38 fl. oz. (100 ml), OTC, Manufactured by: Ma Ying Long Pharmaceutical Group Co., LTD, Wuhan, China; Distributed by: Master Herbs (USA) Inc., NDC 68511-0460-01 | Marketed Without An Approved NDA/ANDA: presence of undeclared morphine. | Master Herbs, Inc./Li / 6024 bottles | Class I | Terminated |
| D-0725-2016 | 01-14-2016 | risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06. | Failed Impurities/Degradation Specifications: Out of specification for a known degradant. | Zydus Pharmaceuticals USA Inc / 9504 Bottles | Class III | Terminated |
| D-0649-2016 | 01-11-2016 | Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1014-68 Package NDCs: 0071-1012-68; 0071-1013-41; 0071-1013-68; 0071-1014-41; 0071-1014-68; 0071-1015-41; 0071-1015-68; 0071-1016-41; 0071-1016-68; 0071-1017-68; 0071-1019-68; 0071-1018-68; 0071-1020-01 | FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules. | Pfizer Inc. / 116,400 bottles | Class II | Terminated |
| D-0648-2016 | 01-11-2016 | Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1013-68 Package NDCs: 0071-1012-68; 0071-1013-41; 0071-1013-68; 0071-1014-41; 0071-1014-68; 0071-1015-41; 0071-1015-68; 0071-1016-41; 0071-1016-68; 0071-1017-68; 0071-1019-68; 0071-1018-68; 0071-1020-01 | FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules. | Pfizer Inc. / 30,672 bottles | Class II | Terminated |
| D-0897-2016 | 01-09-2016 | Germany Niubian, packaged in BIG BOX (10 small boxes / 24 capsules per box / 240 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0903-2016 | 01-09-2016 | Night Man, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0888-2016 | 01-09-2016 | Weekend Prince, packaged in 24 individual cards / 2 capsules per card/ 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0891-2016 | 01-09-2016 | Bull's Genital, packaged in CASE (10 Cans / 10 capsules per can / 100 capsules),Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0900-2016 | 01-09-2016 | Hard Ten Days, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0907-2016 | 01-09-2016 | Zhen Gong Fu, packaged in BIG BOX (16 small boxes / 2 capsules per box / 32 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0904-2016 | 01-09-2016 | Tiger King, packaged in BIG BOX (10 small bottles / 10 capsules per bottle / 100 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0885-2016 | 01-09-2016 | Herb Viagra, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0890-2016 | 01-09-2016 | Bull, packaged in CASE (10 packs / 3 capsules per can / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0884-2016 | 01-09-2016 | Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0905-2016 | 01-09-2016 | Samurai-X, packaged in BIG BOX (24 individually wrapped capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0887-2016 | 01-09-2016 | Stree Overlord, packaged in 10 small boxes / 1 capsule per box, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0894-2016 | 01-09-2016 | Bigger Longer More Time More Sperms, packaged in BIG BOX (6 small boxes / 6 capsules per small box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0906-2016 | 01-09-2016 | Super Hard, packaged in BIG BOX (20 small boxes / 6 capsules per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0889-2016 | 01-09-2016 | African Black Ant, packaged in 8 small boxes / 6 capsules per box / 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0886-2016 | 01-09-2016 | Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0898-2016 | 01-09-2016 | Happy Passengers, packaged in BIG BOX (30 small boxes / 1 capsule per box / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0901-2016 | 01-09-2016 | Man King, packaged in BIG BOX (8 small boxes / 5 capsules per box / 40 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0892-2016 | 01-09-2016 | Zhong Hua Niu Bian, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0893-2016 | 01-09-2016 | African Superman, packaged in BIG BOX (6 small boxes / 8 capsules per box / 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0895-2016 | 01-09-2016 | Black Ant King, packaged in BIG BOX (10 capsules / can / 12 cans per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0902-2016 | 01-09-2016 | Mojo Risen, packaged in BIG BOX (24 individual cards / 2 capsules per card/ 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0899-2016 | 01-09-2016 | Plant Vigra, packaged in BIG BOX / (18 cans / 6 capsules per can / 108 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0896-2016 | 01-09-2016 | Black Storm, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0587-2016 | 01-08-2016 | Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 mL), packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) Sunmark, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: McKesson, San Francisco, CA 94104, NDC 49348-828-34; b) Rite-Aid, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: Rite-Aid, Camp Hill, PA 17011, NDC 11822-0419-1; c) Topcare, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-419-26; d) Kroger, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Distributed by: The Kroger Co., Cincinnati, OH 46202, NDC 30142-419-26; e) GoodSense, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: Perrigo, Allegan, MI 49010, NDC 0113-0419-26; f) Dollar General, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: DolgenCorp, LLC, Goodlettsville, TN 37072, NDC 55910-419-26; g) Care One, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Gluten Free, Distributed by: American Sales Company, Lancaster, NY 14086, NDC 41520-419-26; h) CVS, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Distributed by: CVS Pharmacy Inc, Woonsocket, RI 02895. | Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups. | Perrigo Company PLC / N/A | Class II | Terminated |
| D-0586-2016 | 01-08-2016 | Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) H.E.B. Mucus Relief, Children's Guaifenesin, Expectorant, Age 4+, Grape Flavor, Gluten Free, Alcohol Free, 4 FL OZ (118 mL) Bottle, Made for: H.E.B. San Antonio, TX 78204, NDC 37808-288-26; b) CVS, Children's Mucus Relief Chest Congestion, Guaifenesin, Expectorant, Alcohol free, Gluten free, 4 FL OZ (118 mL) Bottle, For Ages 4 to 12 Years, Grape Flavor Liquid, Dosage Cup Included, Distributed by CVS Pharmacy Inc, One CVS Drive, Woonsocket, RI, 02895, NDC 59779-288-26. | Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups. | Perrigo Company PLC / N/A | Class II | Terminated |
| D-0668-2016 | 01-05-2016 | Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6729-24. Package NDCs: 0409-6729-41; 0409-6729-23; 0409-6729-11; 0409-6729-24; 0409-4121-01; 0409-4121-24; 0409-2050-01; 0409-2050-20; 0409-3164-01; 0409-3164-12; 0409-5239-01; 0409-5239-24 | Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium. | Hospira Inc. / 213,600 bags | Class I | Terminated |
| D-0585-2016 | 01-05-2016 | Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 | Lack of Assurance of Sterility: Failed preservative effectiveness test | Mayne Pharma Usa / a) 52034 bottles and b) 22074 bottles | Class II | Terminated |
