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 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0579-2017 | 02-10-2017 | TRI-BLEACHING CREAM (Retinoic Acid 0.05%, Hydroquinone 8%, Fluocinolone 0.01%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676 | Lack of Assurance of Sterility: There are also CGMP Deviations. | Synergy Rx / N/A | Class II | Terminated |
| D-0552-2017 | 02-10-2017 | CALMING CREAM (Hydrocortisone 2.5%, Aloe vera powder), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676 | Lack of Assurance of Sterility: There are also CGMP Deviations. | Synergy Rx / N/A | Class II | Terminated |
| D-0637-2017 | 02-08-2017 | Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single-Dose Vials per carton (NDC 39822-1030-2); Rx only, Distributed by: X-Gen Pharmaceuticals, Inc., Big Flats, NY 14814; Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. Package NDCs: 39822-1030-1; 39822-1030-2 | Presence of Particulate Matter | X-Gen Pharmaceuticals Inc. / 2593 cartons | Class I | Terminated |
| D-0490-2017 | 02-08-2017 | CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25 Package NDCs: 68084-879-95; 68084-879-25; 68084-921-95; 68084-921-25 | Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities | Amerisource Health Services / 454 cartons | Class II | Terminated |
| D-0517-2017 | 02-07-2017 | Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56 | Failed Impurities/Degradation Specifications | Teva Pharmaceuticals USA / 7,628 HDPE bottles (228,840 tablets) | Class II | Terminated |
| D-0482-2017 | 02-07-2017 | Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsippany, NJ 07054, Repackaged by RemedyRepack, Indiana, PA 15701, NDC 52125-0764-02 | Failed Dissolution Specifications | RemedyRepack Inc. / 630 pills (21 bottles x 30 pills per HDPE bottle) | Class II | Terminated |
| D-0514-2017 | 02-07-2017 | Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05 | Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point. | Actavis Inc / 14280 bottles | Class III | Terminated |
| D-0501-2017 | 02-07-2017 | Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Manufactured by: G&W Laboratories Inc. South Plainfield, NJ 07080, Distributed by Iroko Pharmaceuticals, LLC Philadelphia, PA 19112, NDC 42211-0102-43 | Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing. | G & W Laboratories, Inc. / 3456 boxes | Class II | Terminated |
| D-0642-2017 | 02-03-2017 | Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0924-59 | Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. | SCA Pharmaceuticals / 490 bags | Class I | Terminated |
| D-0641-2017 | 02-03-2017 | Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59 | Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. | SCA Pharmaceuticals / 716 bags | Class I | Terminated |
| D-0644-2017 | 02-03-2017 | Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0929-40 | Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. | SCA Pharmaceuticals / 30 bags | Class I | Terminated |
| D-0645-2017 | 02-03-2017 | Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0918-40 | Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. | SCA Pharmaceuticals / 62 bags | Class I | Terminated |
| D-0639-2017 | 02-03-2017 | Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0922-40 | Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. | SCA Pharmaceuticals / 50 bags | Class I | Terminated |
| D-0475-2017 | 02-03-2017 | CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0 Package NDCs: 60505-0133-0; 60505-0133-2; 60505-0133-1; 60505-0134-0; 60505-0134-2; 60505-0134-1; 3605050134 | Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities. | Apotex Inc. / 19,584 bottles | Class II | Terminated |
| D-0520-2017 | 02-03-2017 | GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21 | Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point. | Amerisource Health Services / 19,393 cartons (581,790 extended release tablets) | Class II | Terminated |
| D-0640-2017 | 02-03-2017 | Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0920-59 | Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. | SCA Pharmaceuticals / 386 bags | Class I | Terminated |
| D-0643-2017 | 02-03-2017 | Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume 515 mL For IV Use Only, Rx Only , SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0925-44 | Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. | SCA Pharmaceuticals / 50 bags | Class I | Terminated |
| D-0481-2017 | 02-02-2017 | Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), packaged in 4-count patches per carton (NDC 66758-208-54), Rx Only, Manufactured by ALZA Corporation, Vacaville, CA 95688 for Sandoz Inc., Princeton, NJ 08540. | Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly. | Sandoz Inc / 157,922 cartons | Class II | Terminated |
| D-0479-2017 | 02-02-2017 | Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960. | Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity. | Teva Pharmaceuticals USA / 17,473 cartons | Class II | Terminated |
| D-0489-2017 | 02-02-2017 | Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Covered Yankauer, 2 Suction Toothbrush packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, and 2 Suction Oral Swab packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, Rx only, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013, Reorder #6306, UPC 6 18029 83041 8. | Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Care kit is printed with an expiration date of November 13, 2017; rather than the correct date of August 28, 2017 (date of expiration of the Corinz Antiseptic Cleansing & Moisturizing Oral Rinse). Note, the correct expiration date of August 28, 2017, is printed on the Corinz Oral Rinse package. | Sage Products Inc / 640 kits | Class III | Terminated |
| D-0860-2017 | 01-30-2017 | Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablets (NDC 50102-128-01), packaged in 3 pouches, each pouch contains one blister pack of 28 tablets (NDC 50102-128-03), Rx only, Manufactured for: Afaxys, Inc., Charleston, SC 29403, USA, Product of India. | Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room. | Mylan Pharmaceuticals Inc. / 43,848 cartons | Class III | Terminated |
| D-0476-2017 | 01-30-2017 | Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4 | Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point. | Actavis Inc / 499320 units | Class II | Terminated |
| D-0861-2017 | 01-30-2017 | Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged in 3 pouches, each contains one blister pack of 21 tablets (NDC 0378-7280-53), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India. Package NDCs: 0378-7280-85; 0378-7280-53 | Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room. | Mylan Pharmaceuticals Inc. / 8,605 cartons | Class III | Terminated |
| D-0493-2017 | 01-27-2017 | Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20 Package NDCs: 51079-086-01; 51079-086-20; 51079-087-01; 51079-087-20; 51079-088-01; 51079-088-20 | Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 58 UD100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) | Class II | Terminated |
| D-0484-2017 | 01-27-2017 | MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%, Phenol 0.5%, 1 oz.. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-210-28 | CGMP Deviations | Cherry Hill Sales Co. / 7,200 cartons | Class II | Terminated |
| D-0485-2017 | 01-27-2017 | MakeSense PHARMA Medicated ANTI-ITCH CREAM WITH SOOTHING ALOE VERA AND VITAMIN E, Camphor-1% Menthol-1%, 1oz.(28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-201-28 | CGMP Deviations | Cherry Hill Sales Co. / 4,800 cartons | Class II | Terminated |
| D-0486-2017 | 01-27-2017 | MakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%, 1 oz. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-208-28 | CGMP Deviations | Cherry Hill Sales Co. / 2,400 cartons | Class II | Terminated |
| D-0603-2017 | 01-27-2017 | Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466 | Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9% | Pharmedium Services, LLC / 3879 syringes | Class III | Terminated |
| D-0487-2017 | 01-27-2017 | MakeSense PHARMA ANTIFUNGAL CREAM Clotrimazole 1%, 1.25 oz. (35 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-203-35 | CGMP Deviations | Cherry Hill Sales Co. / 2,400 cartons | Class II | Terminated |
| D-0483-2017 | 01-27-2017 | MakeSense PHARMA, HEMORRHOIDAL RELIEF CREAM Phenylephrine HCL-0.25% Zinc Oxide-12.50%,1 oz. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-205-28 | CGMP Deviations | Cherry Hill Sales Co. / 3,600 cartons | Class II | Terminated |
| D-0638-2017 | 01-24-2017 | Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01 | Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product. | Hospira Inc., A Pfizer Company / 30,880 vials | Class I | Terminated |
| D-0492-2017 | 01-19-2017 | Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV Package NDCs: 0378-3515-70; 0378-3515-93; 0378-3515-01; 0378-3515-10; 0378-3530-70; 0378-3530-93; 0378-3530-01; 0378-3530-05; 0378-3545-70; 0378-3545-93; 0378-3545-01; 0378-3545-05 | Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle | Mylan Pharmaceuticals Inc. / 37,445 bottles | Class II | Terminated |
| D-0491-2017 | 01-19-2017 | glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10 | Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets | Mylan Pharmaceuticals Inc. / 1338 bottles | Class II | Terminated |
| D-0510-2017 | 01-19-2017 | Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only, Manufactured by: LEO Pharma Inc., Dublin, Ireland, Manufactured for: Prasco Laboratories, Mason, OH, 45040 Package NDCs: 66993-877-61; 66993-877-78 | Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling. | LEO PHARMA INC / 272,062 tubes | Class II | Terminated |
| D-0466-2017 | 01-18-2017 | Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-695-79. Package NDCs: 66689-694-30; 66689-694-79; 66689-694-88; 66689-695-79 | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | VistaPharm, Inc. / 14,368 bottles | Class II | Terminated |
| D-0467-2017 | 01-18-2017 | Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-711-16. | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | VistaPharm, Inc. / 3,354 bottles | Class II | Terminated |
| D-0460-2017 | 01-18-2017 | Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-036-50. | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | VistaPharm, Inc. / 12,059 unit dose cups | Class II | Terminated |
| D-0464-2017 | 01-18-2017 | Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771. | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | VistaPharm, Inc. / 42,776 unit dose cups and 17,403 bottles | Class II | Terminated |
| D-0462-2017 | 01-18-2017 | Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-038-50. | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | VistaPharm, Inc. / 18,437 unit dose cups | Class II | Terminated |
| D-0463-2017 | 01-18-2017 | Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-039-50. | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | VistaPharm, Inc. / 7,404 unit dose cups | Class II | Terminated |
| D-0469-2017 | 01-18-2017 | Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 unit dose cups per case (NDC 66689-047-50), Rx only, Xact Dose, Manufactured by VistaPharm, Largo, FL 33771. | Defective Container: Leakage of unit dose cups that may occur at the seal. | VistaPharm, Inc. / 13,609 cases | Class II | Terminated |
| D-0457-2017 | 01-18-2017 | Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771 | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | VistaPharm, Inc. / 67,955 bottles | Class II | Terminated |
| D-0458-2017 | 01-18-2017 | Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771 | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | VistaPharm, Inc. / 32,027 bottles and 16,310 unit dose cups | Class II | Terminated |
| D-0461-2017 | 01-18-2017 | Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups of 5 mL per case (NDC 66689-037-99), Rx only, Manufactured by VistaPharm, Largo, FL 33771. | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | VistaPharm, Inc. / 55,191 unit dose cups | Class II | Terminated |
| D-0459-2017 | 01-18-2017 | Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-031-50. | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | VistaPharm, Inc. / 3,496 unit dose cups | Class II | Terminated |
| D-0465-2017 | 01-18-2017 | Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 liter (1000 mL), 4 bottles per case, (NDC No. 66689-695-79), Rx only, Manufactured by VistaPharm, Largo, FL 33771. Package NDCs: 66689-694-30; 66689-694-79; 66689-694-88; 66689-695-79; 66689-695-30 | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | VistaPharm, Inc. / 127,193 bottles | Class II | Terminated |
| D-0477-2017 | 01-16-2017 | Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, packaged in (a) 60 g (NDC 50222-501-06), and (b)120 g (50222-501-66) tubes, Rx Only, Manufactured by: LEO Laboratories Ltd., 285 Cashel Road, Dublin 12 Ireland, Distributed by: LEO Pharma Inc. 1 Sylvan Way, Parsippany, NJ 07054. Package NDCs: 50222-501-51; 50222-501-06; 50222-501-66 | Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014. | LEO PHARMA INC / 189,610 units | Class III | Terminated |
| D-0438-2017 | 01-16-2017 | DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56 | Failed Impurities/ Degradation Specifications | Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals / 2568 bottles | Class III | Terminated |
| D-0495-2017 | 01-13-2017 | Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per carton, Rx Only, AbbVie Inc., North Chicago, IL 60064 --- NDC 0074-3012-07 Package NDCs: 0074-3012-07 | Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life | AbbVie Inc. / 4021 cartons, 7 100-mL cassettes each | Class II | Terminated |
| D-0455-2017 | 01-12-2017 | Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles (NDC 62756-519-88), b) 500-count bottles (NDC 62756-519-13) Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat, India. Package NDCs: 62756-517-83; 62756-517-88; 62756-517-08; 62756-517-13; 62756-517-18; 62756-518-83; 62756-518-88; 62756-518-08; 62756-518-13; 62756-518-18; 62756-519-83; 62756-519-88; 62756-519-08; 62756-519-13; 62756-519-18; 62756-985-01; 62756-985-02 | Failed Dissolution Specifications | Sun Pharmaceutical Industries, Inc. / 8,537 bottles | Class II | Terminated |
| D-0439-2017 | 01-12-2017 | Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53 | Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. | Actavis Inc / 164,844 units | Class III | Terminated |
| D-0213-2018 | 01-09-2017 | Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046 INDIA, NDC 43598-611-11 Package NDCs: 43598-611-11; 43598-610-40 | Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off. | Dr. Reddy's Laboratories, Inc. / 1,051 vials | Class II | Terminated |
| D-0623-2017 | 01-07-2017 | Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-726-30 Package NDCs: 31722-726-30; 31722-726-90; 31722-726-01; 31722-726-10; 31722-726-31; 31722-726-32 | Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle. | Hetero USA Inc / 65,664 bottles | Class III | Terminated |
| D-0688-2017 | 01-05-2017 | Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61 Package NDCs: 0904-6500-06; 0904-6500-61; 0904-6501-06; 0904-6501-61 | Failed Dissolution Specifications | The Harvard Drug Group / 2,341 cartons | Class II | Terminated |
| D-0689-2017 | 01-05-2017 | Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6501-61 Package NDCs: 0904-6500-06; 0904-6500-61; 0904-6501-06; 0904-6501-61 | Failed Dissolution Specifications | The Harvard Drug Group / 914 cartons | Class II | Terminated |
| D-0674-2017 | 01-05-2017 | Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0048P, NDC 6897080284 | Subpotent | InnovaGel / Approximately 7,920,177 capsules | Class III | Terminated |
| D-0675-2017 | 01-05-2017 | Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0067P, NDC 6897080284 | Subpotent | InnovaGel / 9,992,768 softgels | Class III | Terminated |
| D-0502-2017 | 01-05-2017 | Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, Gujarat, India, NDC 47335-956-88. Package NDCs: 47335-956-83; 47335-956-81; 47335-956-88; 47335-956-08; 47335-956-18 | Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment. | Sun Pharmaceutical Industries, Inc. / 22,915 bottles | Class II | Terminated |
| D-0680-2017 | 01-04-2017 | Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container, Rx only, Manufactured by Sandoz, Inc., 506 Carnegie Center, Suite 400, Princeton, NJ 08805, Distributed by: McKesson Packaging Services, 7101 Weddington Rd, Concord, NC 28027, NDC 63739-678-10 | Supotent: Out of Specification result for assay test during routine stability testing. | Mckesson Packaging Services / 476 cartons (10x10 blister packs per carton) | Class III | Terminated |
| D-0453-2017 | 12-29-2016 | Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90 Package NDCs: 31722-525-30; 31722-525-01; 31722-525-10; 31722-525-90; 31722-525-05 | Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product. | Hetero Drugs Ltd. - Unit 1 / 20,412 units | Class III | Terminated |
| D-0451-2017 | 12-28-2016 | Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12 Package NDCs: 55111-143-30; 55111-143-01; 55111-143-05; 55111-143-79; 55111-143-78; 55111-144-30; 55111-144-01; 55111-144-05; 55111-144-79; 55111-144-78; 55111-145-71; 55111-145-12; 55111-146-30; 55111-146-01; 55111-146-05; 55111-146-79; 55111-146-78 | Failed Dissolution Specifications; 18 month stability time point | Dr. Reddy's Laboratories, Inc. / 59,440 blister cards | Class II | Terminated |
| D-0449-2017 | 12-28-2016 | Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India Package NDCs: 55111-143-30; 55111-143-01; 55111-143-05; 55111-143-79; 55111-143-78; 55111-144-30; 55111-144-01; 55111-144-05; 55111-144-79; 55111-144-78; 55111-145-71; 55111-145-12; 55111-146-30; 55111-146-01; 55111-146-05; 55111-146-79; 55111-146-78 | Failed Dissolution Specifications; 18 month stability time point | Dr. Reddy's Laboratories, Inc. / a) 2472 bottles, b) 780 bottles | Class II | Terminated |
| D-0450-2017 | 12-28-2016 | Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India Package NDCs: 55111-143-30; 55111-143-01; 55111-143-05; 55111-143-79; 55111-143-78; 55111-144-30; 55111-144-01; 55111-144-05; 55111-144-79; 55111-144-78; 55111-145-71; 55111-145-12; 55111-146-30; 55111-146-01; 55111-146-05; 55111-146-79; 55111-146-78 | Failed Dissolution Specifications; 18 month stability time point | Dr. Reddy's Laboratories, Inc. / a) 42,984 and b) 7,764 bottles | Class II | Terminated |
| D-0452-2017 | 12-28-2016 | Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India Package NDCs: 55111-143-30; 55111-143-01; 55111-143-05; 55111-143-79; 55111-143-78; 55111-144-30; 55111-144-01; 55111-144-05; 55111-144-79; 55111-144-78; 55111-145-71; 55111-145-12; 55111-146-30; 55111-146-01; 55111-146-05; 55111-146-79; 55111-146-78 | Failed Dissolution Specifications; 18 month stability time point | Dr. Reddy's Laboratories, Inc. / a) 38,832 and b) 5,064 bottles | Class II | Terminated |
| D-0434-2017 | 12-28-2016 | Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel, Distributed by Perrigo, Allegan, MI --- NDC 45802-736-84, UPC 345802736840 Package NDCs: 45802-736-84; 3458027368 | Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap | L. Perrigo Company / 162,534 tubes | Class II | Terminated |
| D-0692-2017 | 12-27-2016 | Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04 | Superpotent Drug; out of specification results for assay (manufacturer) | The Harvard Drug Group / 36,990 tablets | Class III | Terminated |
| D-0236-2017 | 12-22-2016 | Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10 | Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%) | Sandoz Incorporated / 96 bottles | Class II | Terminated |
| D-0326-2017 | 12-22-2016 | TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-5891-21 | Failed Stability Specifications | Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals / 1200 bottles | Class III | Terminated |
| D-0474-2017 | 12-22-2016 | Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072 India, NDC 65862-527-30 Package NDCs: 65862-527-47; 65862-527-30; 65862-527-90; 65862-527-01; 65862-527-99; 65862-527-59; 65862-527-10; 65862-528-47; 65862-528-30; 65862-528-90; 65862-528-01; 65862-528-99; 65862-528-35; 65862-528-10; 65862-697-47; 65862-697-30; 65862-697-90; 65862-697-01; 65862-697-05; 65862-697-26; 65862-697-10 | Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules. | Aurobindo Pharma USA Inc / 47,040 bottles | Class II | Terminated |
| D-0437-2017 | 12-22-2016 | Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31. Package NDCs: 0054-4297-31; 0054-4297-25; 0054-8297-25; 0054-4299-31; 0054-4299-25; 0054-8299-25; 0054-4301-29; 0054-4301-25; 0054-8301-25; 0054-3298-63; 0054-3294-50; 0054-3294-46 | Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint. | Roxane Laboratories, Inc. / 6493 bottles | Class II | Terminated |
| D-0440-2017 | 12-21-2016 | Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73 | Subpotency: due to a low, out of specification test result for assay during stability testing. | Teva Pharmaceuticals USA / 133,601 bottles | Class II | Terminated |
| D-0443-2017 | 12-20-2016 | Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA. | Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle. | Mylan LLC. / a) 300 bottles (lot 2006915); b) 156 bottles (lot 2006914) | Class II | Terminated |
| D-0478-2017 | 12-20-2016 | Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17 | Failed tablet/capsule specification: missing break line on the 5mg tablet. | Accord Healthcare, Inc. / 12896 bottles | Class II | Terminated |
| D-0441-2017 | 12-20-2016 | Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA. | Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle. | Mylan LLC. / a) 574 bottles (lot 2006895) and 495 bottles (lot 2006896); b) 744 bottles (lot 2006895) | Class II | Terminated |
| D-0444-2017 | 12-20-2016 | Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98. | Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle. | Mylan LLC. / 588 bottles | Class II | Terminated |
| D-0446-2017 | 12-20-2016 | buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86 | Failed Dissolution Specifications; 18 month stability time point | Sun Pharmaceutical Industries, Inc. / 11,618 bottles | Class III | Terminated |
| D-0442-2017 | 12-20-2016 | Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA. | Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle. | Mylan LLC. / a) 746 bottles (lot 2006903); b)588 bottles (lot 2006902) | Class II | Terminated |
| D-0445-2017 | 12-20-2016 | buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India Package NDCs: 47335-736-86; 47335-736-88; 47335-736-08; 47335-736-13; 47335-737-86; 47335-737-88; 47335-737-08; 47335-737-13; 47335-738-86; 47335-738-88; 47335-738-08; 47335-738-13 | Failed Dissolution Specifications; 18 month stability time point | Sun Pharmaceutical Industries, Inc. / a) 141,068 bottles b) 56,834 bottles c) 61,692 bottles | Class III | Terminated |
| D-0471-2017 | 12-19-2016 | Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3. | Superpotent Drug: Product may not meet specifications throughout shelf life. | Apotex Inc. / 67,946 bottles | Class III | Terminated |
| D-0470-2017 | 12-16-2016 | Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00 Package NDCs: 55150-202-00; 55150-202-10; 55150-202-25 | Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance. | Aurobindo Pharma USA Inc / 29800 vials | Class III | Terminated |
| D-0456-2017 | 12-16-2016 | MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05 Package NDCs: 63323-411-22; 63323-411-27; 63323-411-15; 63323-411-12; 63323-411-18; 63323-411-25; 63323-411-13; 63323-411-10; 63323-412-18; 63323-412-25; 63323-412-03; 63323-412-02; 63323-412-06; 63323-412-05; 63323-412-13; 63323-412-10 | Failed Impurities/Degradation Specifications | Fresenius Kabi USA, LLC / 47, 020 vials | Class II | Terminated |
| D-0242-2017 | 12-15-2016 | Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007 | CGMP Deviations | Gentell, Inc / 3,000 gauzes | Class II | Terminated |
| D-0227-2017 | 12-15-2016 | Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile compounded drug, Hospital/office use only, Not for resale Storage: ROOM TEMP | Lack of Sterility Assurance | Meta Pharmacy Services / 150 mL | Class II | Terminated |
| D-0243-2017 | 12-15-2016 | Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04 | CGMP Deviations | Gentell, Inc / unknown | Class II | Terminated |
| D-0226-2017 | 12-15-2016 | AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320-1799, U.S.A., NDC 76075-102-01 Package NDCs: 76075-101-01; 76075-101-21; 76075-102-01; 76075-102-21; 76075-103-01; 76075-103-21 | Lack of Assurance of Sterility: Potential cracks in glass vials | Amgen, Inc. / 11,434 vials | Class II | Terminated |
| D-0448-2017 | 12-14-2016 | Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99 | Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point.. | Roxane Laboratories, Inc. / 74,108 bottles | Class III | Terminated |
| D-0244-2017 | 12-14-2016 | Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0234-01 | CGMP Deviations | Apotex Corp. / 35,819 bottles (358,190,000 tablets) | Class II | Terminated |
| D-0245-2017 | 12-14-2016 | Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0232-01 | CGMP Deviations | Apotex Corp. / 13,179 bottles (1,317,900 tablets) | Class II | Terminated |
| D-0505-2017 | 12-13-2016 | Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restoration Program. | Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus. | Pacific Medical Solutions / N/A | Class I | Terminated |
| D-0435-2017 | 12-13-2016 | Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz Inc., Princeton, NJ 08540. | Subpotent Drug: out of specification results for assay test. | Sandoz Inc / a) 10,200 bottles; b) 300 bottles | Class III | Terminated |
| D-0693-2017 | 12-12-2016 | Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807 | Failed Dissolution Specifications | Amneal Pharmaceuticals LLC / 105,215 Bottles | Class II | Terminated |
| D-0239-2017 | 12-12-2016 | Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-251-30 | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | VIRTUS PHARMACEUTICALS OPCO II L / 2,406 bottles | Class III | Terminated |
| D-0241-2017 | 12-12-2016 | VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic Acid and DHA, packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-348-30 | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | VIRTUS PHARMACEUTICALS OPCO II L / 124,250 bottles | Class III | Terminated |
| D-0238-2017 | 12-12-2016 | Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing Dietary Supplement, packaged in 90-count bottle, Rx only, Made in Canada, NDC 76439-357-90 | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | VIRTUS PHARMACEUTICALS OPCO II L / 2,537 bottles | Class III | Terminated |
| D-0240-2017 | 12-12-2016 | Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-249-30 | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | VIRTUS PHARMACEUTICALS OPCO II L / 9,795 bottles | Class III | Terminated |
| D-0473-2017 | 12-09-2016 | SLIMFIT X capsules, packaged in a 60-cont bottle | Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine. | Jersey Shore Supplements, LLC / 150 bottles | Class I | Terminated |
| D-0433-2017 | 12-07-2016 | Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0 g sample packets), NDC 69646-704-38 (10 ct. Carton of 1gm samples) / NDC 69646-704-01 (Individual 1gm Samples within Carton), Rx Only, Novum Pharma LLC, Chicago, IL 60654 | Subpotent Drug: Out of specification result for pramoxine hydrochloride | Novum Pharma, LLC / 6,763 1 gram sample packets | Class III | Terminated |
| D-0237-2017 | 12-06-2016 | INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of benzolyl peroxide 3g, 28 capsules of topical tocopherol 5%, OTC, Manufactured for: Innocutis Holdings, LLC, Charleston, SC 29401, NDC 68712-013-01 | Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications. | Cipher Pharmaceuticals US LLC / 216 boxes | Class III | Ongoing |
| D-0206-2017 | 12-06-2016 | Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48. Package NDCs: 0338-6046-48; 0338-6045-37 | Lack of Assurance of Sterility: confirmed customer complaints of leaking bags. | Baxter Healthcare Corporation / 30,910 bags | Class II | Terminated |
| D-0425-2017 | 12-06-2016 | 10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, NDC 0338-1130-06 Package NDCs: 0338-1130-03; 0338-1130-04; 0338-1130-06; 0338-1131-03 | Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch. | Baxter Healthcare Corporation / 3,528 eaches | Class II | Terminated |
