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-1354-2015 | 04-13-2015 | EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP (4 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6244, NDC# 61553-244-61. | Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter. | Pharmedium Services, LLC / 36 bags | Class I | Terminated |
| D-1357-2015 | 04-13-2015 | HEPARIN Sodium Injection USP 25,000 USP Units added to 250 mL 5% Dextrose Injection USP (100 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K0419, NDC# 61553-419-02. | Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter. | Pharmedium Services, LLC / 240 bags | Class I | Terminated |
| D-1353-2015 | 04-13-2015 | oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K2677, NDC# 61553-777-02. | Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter. | Pharmedium Services, LLC / 72 bags | Class I | Terminated |
| D-1355-2015 | 04-13-2015 | HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose Injection USP (50 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K0418, NDC# 61553-418-02. | Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter. | Pharmedium Services, LLC / 480 bags | Class I | Terminated |
| D-0973-2015 | 04-13-2015 | Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3796-01 --- Also labeled under NOVAPLUS label NDC 00409-3796-49 | Crystallization | Hospira Inc. / | Class II | Terminated |
| D-0972-2015 | 04-13-2015 | Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3795-01--- Also labeled under NOVAPLUS label NDC 00409-3795-49 | Crystallization | Hospira Inc. / | Class II | Terminated |
| D-0971-2015 | 04-13-2015 | Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960 Package NDCs: 50111-647-01; 50111-647-02; 50111-647-03; 50111-648-01; 50111-648-02; 50111-648-03; 50111-648-44 | Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity. | Teva Pharmaceuticals USA / | Class II | Terminated |
| D-0970-2015 | 04-13-2015 | Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC 50111-647-01 Package NDCs: 50111-647-01; 50111-647-02; 50111-647-03; 50111-648-01; 50111-648-02; 50111-648-03; 50111-648-44 | Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity. | Teva Pharmaceuticals USA / | Class II | Terminated |
| D-1088-2015 | 04-12-2015 | Testosterone Cypionate 200 mg/mL in Sesame oil, 10 mL amber glass vial, Rx Only, Lot# T-1201S14, Compounded by Strohecker's Pharmacy. | Incorrect Product Formulation: Vials labeled as Testosterone Cypionate 200 mg/mL in Sesame Oil are being recalled because they contains Estradiol Valerate 20 mg/mL. | Stroheckers Inc Pharmacy / 365 vials | Class I | Terminated |
| D-1084-2015 | 04-10-2015 | ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05 | Failed pH specification | Oasis Medical, Inc. / 9,731 cartons | Class III | Terminated |
| D-1077-2015 | 04-10-2015 | MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per case, over-the-counter, Distributed by INSIGHT Pharmaceuticals, LLC, Trevose, PA 19053-8433, NDC 63736-013-30 Package NDCs: 63736-013-30 | Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA requires both a 1200 mg vaginal suppository and the 2% topical cream. | Medtech Products, Inc. / 4,175 cases (50,100 ovules); and 6 cases (72 ovules) as company samples | Class III | Terminated |
| D-0490-2015 | 04-07-2015 | 0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-7101-67 Package NDCs: 0409-7101-68; 0409-7101-66; 0409-7101-69; 0409-7101-67; 0409-7101-04; 0409-7101-02; 0409-7132-68; 0409-7132-66; 0409-7132-69; 0409-7132-67; 0409-7132-04; 0409-7132-02 | Lack of Sterility Assurance: The product has the potential to leak at the administrative port. | Hospira Inc. / 128,050 ADD-Vantage flexible containers | Class II | Terminated |
| D-1080-2015 | 04-07-2015 | Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9 | Subpotent drug | Apotex Inc. / 6,467 bottles/ blister cartons | Class III | Terminated |
| D-1129-2015 | 04-07-2015 | Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16 | Failed Impurities/Degradation Specifications | Akorn, Inc. / 424,174 bottles | Class II | Terminated |
| D-1081-2015 | 04-07-2015 | Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9 | Subpotent drug | Apotex Inc. / 5,352 bottles | Class III | Terminated |
| D-1079-2015 | 04-07-2015 | Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9 | Subpotent drug | Apotex Inc. / 23,274 bottles/ blister cartons | Class III | Terminated |
| D-1130-2015 | 04-07-2015 | Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16 | Failed Impurities/Degradation Specifications | Akorn, Inc. / N/A | Class II | Terminated |
| D-1085-2015 | 04-02-2015 | Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC a) 0054-0141-20, b) 0054-0141-25 Package NDCs: 0054-0140-25; 0054-0141-20; 0054-0141-25; 0054-0142-25 | Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point. | Boehringer Ingelheim Roxane Inc / a) 575 Blister Packs, b) 12,802 Bottles | Class II | Completed |
| D-0992-2015 | 03-31-2015 | C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC 0527-1728-74), Rx Only, Manufactured for Lannett Company, Inc. Philadelphia, PA 19136 by Cody Laboratories, Inc. Cody, WY 82414 | Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL | Cody Laboratories, Inc. / 19,139 bottles | Class II | Terminated |
| D-1083-2015 | 03-26-2015 | Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, USA, NDC 51079-547-20 | Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 1,363 UD Cartons | Class III | Terminated |
| D-0488-2015 | 03-26-2015 | Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA --- NDC 62037-0600-90 | Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell | Actavis Laboratories, FL, Inc. / 2,628 bottles | Class III | Terminated |
| D00432-2015 | 03-25-2015 | PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydrochloride 5 mg, alcohol 7%, (a) 4 fl oz bottle (NDC 0603-1588-54) and (b) 16 fl oz bottle (NDC 0603-1588-58) Rx only, Manufactured for QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811. | Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point. | Qualitest Pharmaceuticals / 36,732 units | Class III | Terminated |
| D-0436-2015 | 03-25-2015 | GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724, NDC: 23155-116-01. Package NDCs: 23155-115-01; 23155-115-10; 23155-116-01; 23155-116-10; 23155-117-01; 23155-117-10 | Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. | Heritage Pharmaceuticals, Inc. / 6,816 Bottles | Class II | Terminated |
| D-1210-2015 | 03-24-2015 | 10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0023-02 Package NDCs: 0338-0017-10; 0338-0017-41; 0338-0017-11; 0338-0017-31; 0338-0017-48; 0338-0017-18; 0338-0017-38; 0338-0017-02; 0338-0017-03; 0338-0017-04; 0338-0023-02; 0338-0023-03; 0338-0023-04 | Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) | Baxter Healthcare Corp. / 18,324 bags | Class I | Terminated |
| D-1209-2015 | 03-24-2015 | 5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0017-02 Package NDCs: 0338-0017-10; 0338-0017-41; 0338-0017-11; 0338-0017-31; 0338-0017-48; 0338-0017-18; 0338-0017-38; 0338-0017-02; 0338-0017-03; 0338-0017-04; 0338-0023-02; 0338-0023-03; 0338-0023-04 | Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) | Baxter Healthcare Corp. / 402,284 bags | Class I | Terminated |
| D-1211-2015 | 03-24-2015 | Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0117-02 Package NDCs: 0338-0117-02; 0338-0117-03; 0338-0117-04 | Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) | Baxter Healthcare Corp. / 58,932 bags | Class I | Terminated |
| D-1208-2015 | 03-24-2015 | 0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0049-02 Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) | Baxter Healthcare Corp. / 202,824 Bags | Class I | Terminated |
| D-0961-2015 | 03-24-2015 | Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, individually wrapped strip (NDC 51801-003-01), barcode (01)00351801003012, packaged in a) 100-count strips per carton (NDC 51801-003-40, UPC 3 51801 00340 1); and b) 300-count strips per carton (NDC 51801-003-50, UPC 3 51801 00350 0), Nomax, Inc., St. Louis, MO 63123 USA; and 2) FUL-GLO, individually wrapped strip (NDC 1748-403-03), barcode (01)00317478403036, packaged in 300-count strips per carton (NDC 17478-403-030, UPC 3 17478-403-03 6), Manufactured for: Akorn, Inc., Lake Forest, IL 60045. Package NDCs: 51801-003-50; 51801-003-40; 51801-003-01; 0035180100; 0031747840; 17478-403-03 | Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips. | Nomax Inc / 23,201 cartons | Class III | Terminated |
| D-0963-2015 | 03-24-2015 | Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO, individually wrapped strips, barcode (01)00317478404019; packaged in 100-count strips per carton, (NDC 17478-404-01), UPC 3 17478 40401 9, Manufactured for: Akorn, Inc., Lake Forest, IL 60045.; and 2)Fluorescein Pro Glo Strips, individually wrapped strips, barcode (01)00360843000026, packaged in 300-count strips per carton, (NDC 60843-300-50), UPC 3 60843 30050 8, Manufactured for Eye Care and Cure by Nomax, Inc., St. Louis, MO 63123. | Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips. | Nomax Inc / 62,691 cartons | Class III | Terminated |
| D-0962-2015 | 03-24-2015 | Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, individually wrapped strip (NDC 51801-004-01), barcode (01)00351801004019, packaged in 100-count strips per carton (NDC 51801-004-40, UPC 3 51801 00440 8), Nomax, Inc., St. Louis, MO 63123 USA. Package NDCs: 51801-004-40; 51801-004-01; 0035180100 | Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of rose bengal present in the strips. | Nomax Inc / 5,514 cartons | Class III | Terminated |
| D-1333-2015 | 03-23-2015 | Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-463-02, UPC 3 67457 46302 5. | Presence of Particulate Matter | Mylan Institutional LLC / 2,455 vials | Class I | Terminated |
| D-1332-2015 | 03-23-2015 | Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-464-20, UPC 3 67457 46420 6; and b) Distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY 10017, Made in India, NDC 0069-3857-10, UPC 3 00693 85710 4. | Presence of Particulate Matter | Mylan Institutional LLC / a) 35,197 vials; b) 21,302 vials | Class I | Terminated |
| D-1334-2015 | 03-23-2015 | Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1. | Presence of Particulate Matter | Mylan Institutional LLC / 10,094 vials | Class I | Terminated |
| D-0429-2015 | 03-23-2015 | 0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31 Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | Lack of Assurance of Sterility; increased complaints received for leaks | Baxter Healthcare Corp / 196,128 containers | Class II | Terminated |
| D-0428-2015 | 03-23-2015 | Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04 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 | Lack of Assurance of Sterility; increased complaints received for leaks | Baxter Healthcare Corp / 7444 containers | Class II | Terminated |
| D-0426-2015 | 03-18-2015 | 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04 Package NDCs: 0338-0017-10; 0338-0017-41; 0338-0017-11; 0338-0017-31; 0338-0017-48; 0338-0017-18; 0338-0017-38; 0338-0017-02; 0338-0017-03; 0338-0017-04; 0338-0023-02; 0338-0023-03; 0338-0023-04 | Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility. | Baxter Healthcare Corp. / 48,874 | Class II | Terminated |
| D-0425-2015 | 03-18-2015 | 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03 Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility. | Baxter Healthcare Corp. / 597,498 units total | Class II | Terminated |
| D-1331-2015 | 03-18-2015 | CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-493-46, UPC 3 67457 49346 6. | Presence of Particulate Matter | Mylan Institutional LLC / 4,445 vials | Class I | Terminated |
| D-1328-2015 | 03-18-2015 | Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-0146-01; and b) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-467-99. | Presence of Particulate Matter | Mylan Institutional LLC / a) 15,095 vials b) 300 vials | Class I | Terminated |
| D-0997-2015 | 03-17-2015 | SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701 | Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. | Akorn, Inc. / 8,400 unit dose cups (20 mL each) | Class II | Terminated |
| D-1072-2015 | 03-17-2015 | Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 4 vials | Class II | Terminated |
| D-1075-2015 | 03-17-2015 | Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 70 vials | Class II | Terminated |
| D-1073-2015 | 03-17-2015 | Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 8 vials | Class II | Terminated |
| D-1066-2015 | 03-17-2015 | Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 30 vials | Class II | Terminated |
| D-1068-2015 | 03-17-2015 | Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injection, 5) 80 mcg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 43 vials | Class II | Terminated |
| D-1069-2015 | 03-17-2015 | Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 15 vials | Class II | Terminated |
| D-1067-2015 | 03-17-2015 | Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 12 vials | Class II | Terminated |
| D-1070-2015 | 03-17-2015 | Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 8 vials | Class II | Terminated |
| D-0995-2015 | 03-17-2015 | SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701 | Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. | Akorn, Inc. / 27,648 bottles (16 fl. oz. each) | Class II | Terminated |
| D-1071-2015 | 03-17-2015 | Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 6 vials | Class II | Terminated |
| D-0996-2015 | 03-17-2015 | SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701 | Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. | Akorn, Inc. / 326,666 bottles (16 fl. oz. each) | Class II | Terminated |
| D-1074-2015 | 03-17-2015 | Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL, 6) 1000mcg/mL and 7) 1000 mcg/0.04mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 | Lack of assurance of sterility | Fallon Wellness Pharmacy, L.L.C. / 56 vials | Class II | Terminated |
| D-0975-2015 | 03-12-2015 | Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt USA LLC., 20 Waterview Boulevard, Parsippany, NJ 07054 USA | Failed Tablet/Capsule Specifications: out of specification for thickness. | Wockhardt Usa Inc. / 93,393 bottles | Class II | Terminated |
| D-0435-2015 | 03-11-2015 | Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count Bottles, NDC 0378-0781-91, b) 500 count Bottles, NDC 0378-0781-05, Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, USA. | Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine. | Mylan Pharmaceuticals Inc. / 13,856 Bottles | Class III | Terminated |
| D-1108-2015 | 03-11-2015 | LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08. | Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold | Hospira Inc. / 24,744 flexible container bags | Class I | Terminated |
| D-0423-2015 | 03-10-2015 | AIR COMPRESSED, Medical Air, USP, Rx Only. Matheson Tri-Gas, Inc., 150 Allen Road, Basking Ridge, NJ 07920. Available in A) E or 22 cu ft cylinder, NDC: 55037-302-09; B) 40 cu ft cylinder, NDC: 55037-302-10; C) 200 cu ft cylinder, NDC: 55037-302-15; D) 220 cu ft cylinder, NDC: 55037-302-16; E) 300 cu ft cylinder, NDC: 55037-302-18, 55037-302-19, 55037-302-20. Package NDCs: 55037-302-01; 55037-302-02; 55037-302-03; 55037-302-04; 55037-302-05; 55037-302-06; 55037-302-07; 55037-302-08; 55037-302-09; 55037-302-10; 55037-302-11; 55037-302-12; 55037-302-13; 55037-302-14; 55037-302-15; 55037-302-16; 55037-302-17; 55037-302-18; 55037-302-19; 55037-302-20 | Failed Impurities/Degradation Specification; out of specification results for carbon dioxide | Matheson, Inc. / 137,880 cubic feet | Class III | Terminated |
| D-0208-2016 | 03-10-2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) VAN CR (vanishing cream) W/V (weight/volume) (4812) 2.5MG/ML Transdermal cream, dispensed in a) 1mL and b)3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 1(1mL) syringe, 56 (3mL) syringes | Class II | Terminated |
| D-0193-2016 | 03-10-2015 | BIEST TD 80/20 (estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 2.5MG/ML Transdermal cream, dispensed in a) 3 mL and b) 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 30 (3mL) syringes, 9 (10mL) syringes | Class II | Terminated |
| D-0224-2016 | 03-10-2015 | ESTRIOL (E3) W/V (weight/volume) VERSABASE [4714] 0.05% (0.5MG/ML) transdermal cream, dispensed in a) 1 mL and b) 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 10 (3mL) syringes, 20 (1mL) syringes | Class II | Terminated |
| D-0190-2016 | 03-10-2015 | BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 8 MG/ML transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 5 (3mL) syringes | Class II | Terminated |
| D-0200-2016 | 03-10-2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 3: 25: 1.25: 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 12 (10mL) syringes | Class II | Terminated |
| D-0221-2016 | 03-10-2015 | ESTRIOL (E3) 2.5MG suppositories, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 20 suppositories | Class II | Terminated |
| D-0991-2015 | 03-10-2015 | ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 capsule bottles, Manufactured and distributed by: Ultra ZX Labs, L.L.C. 2525 SW 3rd Ave Apt 1704 Miami, Florida 33129-2068. | Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein | Ultra ZX Supplements / 636 bottles | Class I | Terminated |
| D-0216-2016 | 03-10-2015 | ESTRIOL (E3) : PROGESTERONE W/V (weight/volume) 4.0 : 100 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 40 (3mL) syringes | Class II | Terminated |
| D-0217-2016 | 03-10-2015 | ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosterone USP) W/V (weight/volume) 2 :0.1 : 35 : 0.5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 6 (10mL) syringes | Class II | Terminated |
| D-0201-2016 | 03-10-2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 6.5 : 30: 1.25: 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 12 (10mL) syringes | Class II | Terminated |
| D-0219-2016 | 03-10-2015 | ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : TESTO (Testosterone USP) W/V (weight/volume) 2.0: 0.1: 0.5MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 9 (5mL) syringes | Class II | Terminated |
| D-0223-2016 | 03-10-2015 | ESTRIOL (E3) W/V (weight/volume) VERSABASE 3MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 6 (5mL) syringes | Class II | Terminated |
| D-0187-2016 | 03-10-2015 | BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 2.5 MG/ML transdermal cream, dispensed in 10 mL prefilled syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 3 (10mL) syringes | Class II | Terminated |
| D-0220-2016 | 03-10-2015 | ESTRIOL (E3) : TESTO (Testosterone USP) WV (weight/volume) 0.5MG : 2MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 30 (3mL) syringes | Class II | Terminated |
| D-0206-2016 | 03-10-2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) W/V (weight/volume) 1.25:100:0.625 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 12 (10mL) syringes | Class II | Terminated |
| D-0189-2016 | 03-10-2015 | BIEST TD 67/33 (Estradiol (E2) TRIT (YELLOW)/Estriol USP Micronized (E3)) W/V (weight /volume) 1.5 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 10 (3mL) syringes | Class II | Terminated |
| D-0191-2016 | 03-10-2015 | BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 6 (10mL) syringes | Class II | Terminated |
| D-0198-2016 | 03-10-2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 5.0 : 30 : 2.5 : 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 26 (10mL) syringes | Class II | Terminated |
| D-0210-2016 | 03-10-2015 | BIEST TD 86/14 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) IN PLO GEL (Pluronic F127 20% or Polox 20% gel) 2.9 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 20 (3mL) syringes | Class II | Terminated |
| D-0215-2016 | 03-10-2015 | ESTRIOL (E3) : PROGESTERONE : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 4.0 : 30 : 4MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 3 (10mL) syringes | Class II | Terminated |
| D-0183-2016 | 03-10-2015 | BIEST 80/20 : PROGEST : DHEA : TESTOST (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow): Progesterone USP: Dehydroepiandrosterone Micronized (DHEA): Testosterone Trit ) 2.5 : 25 : 2.5 : 0.1MG TROCHE, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 60 troches | Class II | Terminated |
| D-0204-2016 | 03-10-2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 2.5 : 17.5 : 1.25 :0.25MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 12 (10mL) syringes | Class II | Terminated |
| D-0227-2016 | 03-10-2015 | TRIEST 80/10/10 (E1/E2 Trit - Estrone (E1)/Estradiol (E2) / Estriol USP (E3)) (23) 5MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 120 capsules | Class II | Terminated |
| D-0184-2016 | 03-10-2015 | BIEST CP 76/24: DHEA (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow) : Dehydroepiandrosterone Micronized (DHEA) 2.625 MG : 10 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 90 capsules | Class II | Terminated |
| D-0182-2016 | 03-10-2015 | BIEST 66/34: TESTOSTERONE : PROGESTERONE IN OLIVE OIL(Estradiol USP Micronized (ED)/Estriol USP Micronized (E3): Testosterone : Progesterone in Olive Oil) 3mg : 4 mg : 100 mg/mL suspension, Rx only, packaged in a 15 mL glass dropper bottle. The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 3 (15mL) bottles | Class II | Terminated |
| D-0228-2016 | 03-10-2015 | TRIEST 80/10/10 (Estrone (E1) Trit / Estradiol (E2) Trit / Estriol USP (E3)) 1.875MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 60 capsules | Class II | Terminated |
| D-0194-2016 | 03-10-2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 6 (10mL) syringes | Class II | Terminated |
| D-0186-2016 | 03-10-2015 | BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 2.5 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 180 capsules | Class II | Terminated |
| D-0202-2016 | 03-10-2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) IN VERSABASE W/V (weight/volume) 2.5 : 25 :1.25MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 66 (10mL) syringes | Class II | Terminated |
| D-0218-2016 | 03-10-2015 | ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosterone USP) W/V (weight/volume) 2 :0.1 : 30 : 0.5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 5 (10mL) syringes | Class II | Terminated |
| D-0214-2016 | 03-10-2015 | ESTRIOL (E3) 4.0MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 90 capsules | Class II | Terminated |
| D-0211-2016 | 03-10-2015 | BIEST TD 89/11 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) VERSABASE 2.25MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 10 (3mL) syringes | Class II | Terminated |
| D-0199-2016 | 03-10-2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) 2.5 : 20 : 1.25 : 0.25 MG/ML TRANSDERMAL (Cream)Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 6 (10mL) syringes | Class II | Terminated |
| D-0185-2016 | 03-10-2015 | BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 1.25 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 240 capsules | Class II | Terminated |
| D-0222-2016 | 03-10-2015 | ESTRIOL (E3) W/V (weight/volume) PGF 0.1% (1.0MG/ML) Transdermal cream, is dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 10 (3mL) syringes | Class II | Terminated |
| D-0212-2016 | 03-10-2015 | BIEST TD 91/9 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) : PROGESTERONE W/V (weight/volume) PLO (Pluronic F127 20% or Polox 20% gel) 3.3 MG/ML : 40 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 10 (10mL) syringes | Class II | Terminated |
| D-0209-2016 | 03-10-2015 | BIEST TD 83/17 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) 1.2 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 6 (10mL) syringes | Class II | Terminated |
| D-0567-2016 | 03-10-2015 | Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 52372-0898-02), c) 100 gm (NDC: 52372-0898-03), and d) 500 gm (NDC: 52372-0898-04), Cas No. 57808-66-9, Rx only, FREEDOM, 801 W. New Orleans St., Broken Arrow, OK 74011. | Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin. | Freedom Pharmaceuticals Inc / 20 kg | Class II | Terminated |
| D-0188-2016 | 03-10-2015 | BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 4.0 MG/ML transdermal cream packaged in 3mL syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 5 (3mL) syringes | Class II | Terminated |
| D-0192-2016 | 03-10-2015 | BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 12.5 MG/ML 1.25MG/0.1ML Transdermal cream, dispensed in 1 mL prefilled, amber syringes,Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 9 (1mL) syringes | Class II | Terminated |
| D-0196-2016 | 03-10-2015 | BIEST TD 80/20 (Estradiol (E2) Trit (yellow) / Estriol USP Micronized (E3)): PROG (Progesterone USP Micronized) W/V 2.5MG:100MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 15 (3 mL) syringes | Class II | Terminated |
| D-0195-2016 | 03-10-2015 | BIEST TD 80/20 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) W/V(weight/volume) [2977] 6.25MG/ML Transdermal cream, dispensed in 1 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 36 (1 mL) syringes | Class II | Terminated |
| D-0205-2016 | 03-10-2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) W/V (weight/volume) 5.0 :20 :1 MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 15 (5mL) syringes | Class II | Terminated |
| D-0226-2016 | 03-10-2015 | TRIEST 70/20/10 ( Estriol USP / Estradiol USP (E2) / Estrone (E1) Triturate) [909] 12.5MG/ML transdermal cream, dispensed in 1 mL prefilled amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506. | Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. | the Compounder / 24 (1mL) syringes | Class II | Terminated |
