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-1483-2014 | 06-19-2014 | Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC | Failed Dissolution Specification; at the 12 month time interval. | Mckesson Packaging Services / 1,511,250 tablets | Class III | Terminated |
| D-1485-2014 | 06-19-2014 | Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., New York, NY 10017, NDC 0049-2710-30 | Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant. | Pfizer Inc. / 22,461 bottles | Class III | Terminated |
| D-0002-2015 | 06-17-2014 | Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-1560-29 Package NDCs: 0409-1559-18; 0409-1559-10; 0409-1559-19; 0409-1559-30; 0409-1560-18; 0409-1560-10; 0409-1560-19; 0409-1560-29; 0409-1582-18; 0409-1582-10; 0409-1582-19; 0409-1582-29; 0409-1587-50; 0409-1610-50; 0409-1746-70; 0409-1746-10; 0409-1746-71; 0409-1746-30; 0409-1749-70; 0409-1749-10; 0409-1749-71; 0409-1749-29; 0409-1752-50; 0409-1755-50; 0409-2510-01; 0409-2510-25; 0409-7535-01; 0409-7535-25; 0409-1250-01; 0409-1250-25; 0409-5010-01; 0409-5010-25; 0409-1530-01; 0409-1530-25; 0409-0525-01; 0409-0525-25; 0409-7510-01; 0409-7510-25; 0409-2253-01; 0409-2253-25 | Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution. | Hospira Inc. / 40,730 vials | Class I | Terminated |
| D-1439-2014 | 06-17-2014 | Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67 Package NDCs: 0555-9051-79; 0555-9051-67 | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Teva Pharmaceuticals USA / 5265 blister packs | Class III | Terminated |
| D-1437-2014 | 06-17-2014 | Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58 | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Teva Pharmaceuticals USA / 984 blister packs | Class III | Terminated |
| D-1436-2014 | 06-17-2014 | Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58 Package NDCs: 0555-9043-79; 0555-9043-58 | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Teva Pharmaceuticals USA / 1104 blister packs | Class III | Terminated |
| D-1438-2014 | 06-17-2014 | Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58 Package NDCs: 0555-9050-79; 0555-9050-58 | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Teva Pharmaceuticals USA / 1125 blister packs | Class III | Terminated |
| D-1413-2014 | 06-16-2014 | Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1415, NDC 10019-055-61. Package NDCs: 10019-115-39; 10019-115-01; 10019-075-87; 10019-055-61 | Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating. | Baxter Healthcare Corp. / 20,810 containers | Class II | Terminated |
| D-1383-2014 | 06-12-2014 | Captomer [succinic acid (from 100 mg DMSA)] capsules, 65 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 74002 5 | Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs. | Thorne Research Inc / unknown | Class II | Terminated |
| D-1384-2014 | 06-12-2014 | Captomer-250 [succinic acid (from 250 mg DMSA)] capsules, 162 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 73502 1 | Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs. | Thorne Research Inc / unknown | Class II | Terminated |
| D-1415-2014 | 06-12-2014 | Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. 30-Count Bottle NDC: 41616-758-83, 90-Count Bottle: NDC 41616-758-81. | Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications. | Caraco Pharmaceutical Laboratories, Ltd. / 26,530 30-Count Bottles; 14,597 90-Count Bottles | Class II | Terminated |
| D-1452-2014 | 06-06-2014 | DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories Darphin, Dist, Paris France | Stability Data Does Not Support Expiry | Estee Lauder Inc / 3,791 tubes | Class III | Terminated |
| D-1425-2014 | 06-06-2014 | Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7793-62 Package NDCs: 0409-7793-52; 0409-7793-62; 0409-7793-13; 0409-7793-23; 0409-7794-52; 0409-7794-62; 0409-4520-02; 0409-4520-30 | Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag. | Hospira Inc. / 142,152 bags | Class II | Terminated |
| D-1538-2014 | 06-05-2014 | Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jeruselem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA, NDC 0093-0293-10 | Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets. | Teva Pharmaceuticals USA / 3881bottles | Class II | Terminated |
| D-0053-2015 | 06-05-2014 | APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE bottle (NDC 0024-5812-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7 | Labeling: Incorrect or Missing Package Insert | Valeant Pharmaceuticals North America LLC / 55,650 HDPE bottles | Class III | Terminated |
| D-0051-2015 | 06-05-2014 | APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE bottle, Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7, NDC 0024-5810-07. | Labeling: Incorrect or Missing Package Insert | Valeant Pharmaceuticals North America LLC / 20,499 HDPE bottles | Class III | Terminated |
| D-0052-2015 | 06-05-2014 | APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-count HDPE bottle (NDC 0024-5811-07), b) 30-count HDPE bottle (NDC 0024-5811-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7 | Labeling: Incorrect or Missing Package Insert | Valeant Pharmaceuticals North America LLC / 23,057 HDPE bottles | Class III | Terminated |
| D-0017-2015 | 06-02-2014 | Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808 | Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked in unit dose packslabeled as Atorvastatin Calcium | Unit Dose Solutions Inc / 1,177 packets | Class II | Terminated |
| D-1512-2014 | 06-02-2014 | Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6. Package NDCs: 25682-001-01 | Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition. | Alexion Pharmaceuticals, Inc. / 96,506 vials | Class I | Terminated |
| D-1420-2014 | 05-30-2014 | HCG (Human Chorionic Gonadotropin) 200 units/ 0.1 mL drops, packaged in 5 mL and 10 mL bottles, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 | Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. | Brookfield Prescription Center Inc. dba MD Custom Rx / 55 mL | Class II | Terminated |
| D-1418-2014 | 05-30-2014 | HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 | Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. | Brookfield Prescription Center Inc. dba MD Custom Rx / 184 mL | Class II | Terminated |
| D-1416-2014 | 05-30-2014 | Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 | Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. | Brookfield Prescription Center Inc. dba MD Custom Rx / 6000 mL | Class II | Terminated |
| D-1419-2014 | 05-30-2014 | HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 | Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. | Brookfield Prescription Center Inc. dba MD Custom Rx / 850 tablets | Class II | Terminated |
| D-1417-2014 | 05-30-2014 | Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 | Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. | Brookfield Prescription Center Inc. dba MD Custom Rx / 30 mL | Class II | Terminated |
| D-1421-2014 | 05-30-2014 | HCG (Human Chorionic Gonadotropin) + Methylcobalamin (Methyl B12), 1500 units + 1000 mcg/mL drop, 8 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 | Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. | Brookfield Prescription Center Inc. dba MD Custom Rx / 8 mL | Class II | Terminated |
| D-1430-2014 | 05-29-2014 | Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56 Package NDCs: 0093-7442-56; 0093-7442-01; 0093-7443-56; 0093-7443-01 | Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage. | Teva Pharmaceuticals USA / 8,472 Bottles | Class II | Terminated |
| D-1559-2014 | 05-28-2014 | PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 | Non Sterility; microbial contamination identified as Aspergillus species | Central Admixture Pharmacy Services, Inc. / 1 dose | Class I | Terminated |
| D-1562-2014 | 05-28-2014 | LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 | Non Sterility; microbial contamination identified as Aspergillus species | Central Admixture Pharmacy Services, Inc. / 4 doses | Class I | Terminated |
| D-1387-2014 | 05-28-2014 | Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck, Sharpe & Dohne Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, Manufactured by: Novartis Pharma AG Basle, Switzerland NDC 0085-1401-01 | Failed Stability Specification; out of specification result for particle size distribution during stability testing | Novartis Pharmaceuticals Corp. / Lot F0067: 45,834 units; Lot F0079: 63,321 units | Class III | Terminated |
| D-1560-2014 | 05-28-2014 | del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 | Non Sterility; microbial contamination identified as Aspergillus species | Central Admixture Pharmacy Services, Inc. / 31 doses | Class I | Terminated |
| D-1561-2014 | 05-28-2014 | adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 | Non Sterility; microbial contamination identified as Aspergillus species | Central Admixture Pharmacy Services, Inc. / 5 doses | Class I | Terminated |
| D-1381-2014 | 05-23-2014 | Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories Limited, Batchupally - 500 090 India. NDC55111-466-01 Package NDCs: 55111-466-30; 55111-466-60; 55111-466-01; 55111-466-05; 55111-466-79; 55111-466-78; 55111-467-30; 55111-467-60; 55111-467-01; 55111-467-05; 55111-467-79; 55111-467-78 | Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point. | Dr. Reddy's Laboratories, Inc. / 13560 bottles | Class II | Terminated |
| D-1350-2014 | 05-22-2014 | Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540. NDC 0781-5439-20. Package NDCs: 0781-5438-20; 0781-5438-01; 0781-5439-20; 0781-5439-01 | Presence of Foreign Substance: Presence of stainless steel particles. | Sandoz, Inc / 22,818 Bottles | Class II | Terminated |
| D-0042-2015 | 05-22-2014 | Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India | Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg | Aidarex Pharmaceuticals LLC / 531 bottles | Class II | Terminated |
| D-0018-2015 | 05-21-2014 | Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada Package NDCs: 0187-0146-01 | Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset | Valeant Pharmaceuticals North America LLC / 205,853 bottles | Class III | Terminated |
| D-0019-2015 | 05-21-2014 | Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada 2.5 mg 90 ct - NDC 0187-0140-90 5 mg 30 ct - NDC 0187-0141-30 5 mg 90 ct - NDC 0187-0141-90 10 mg 30 ct - NDC 0187-0142-30 10 mg 90 ct - NDC 0187-0142-90 10 mg 1000 ct - NDC 0187-0142-10 20 mg 30 ct - NDC 0187-0143-30 20 mg 90 ct - NDC 0187-0143-90 20 mg 1000 ct - NDC 0187-0143-10 NDC #'s 64455-140, 64455-141, 64455-142 and 64455-143, 30 ct. bottles, 90 ct. bottles and 1000 ct. bottles Package NDCs: 0187-0140-30; 0187-0140-90; 0187-0141-30; 0187-0141-90; 0187-0141-10; 0187-0142-30; 0187-0142-90; 0187-0142-10; 0187-0143-30; 0187-0143-90; 0187-0143-10 | Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert. | Valeant Pharmaceuticals North America LLC / 205,853 bottles | Class III | Terminated |
| D-0447-2017 | 05-20-2014 | Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside Poly-lined cardboard drums. Net weight 40 kg | Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product. | Cambrex Charles City Inc / 2351.12 pound container | Class II | Terminated |
| D-1414-2014 | 05-20-2014 | Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000-count bottles, NDC 61748-013-10, Mfd. for: VersaPharm Incorporated, Marietta, GA 30062; Mfd. by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724. | Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point. | West-Ward Pharmaceutical Corp. / a) 17,347 bottles, b) 3,015 bottles, c) 1,334 bottles, d) 5,651 bottles, e) 210 bottles | Class II | Terminated |
| D-1548-2014 | 05-16-2014 | ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe, For IV, IM, or SC injection, Preservative Free, For Office/Hospital Use Only, Protect from Light, 62295-3084-05, US Compounding Pharmacy, Conway, AR 800-718-3588 | Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine sulfate injection syringes are stored, were mislabeled with 25 mg/mL in big font and 5 mg/mL in small font, however, the actual syringes were correctly labeled as 25 mg/5 mL. | US Compounding Inc / 762 Syringes | Class II | Terminated |
| D-1386-2014 | 05-16-2014 | Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx Only. Mfd. for: Watson Pharma Inc., Parsippany, NJ 07054 USA. Mfd. by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237 USA. NDC 0591-3561-15. | Subpotent Drug. | Actavis Inc / 6913 packages | Class II | Terminated |
| D-1424-2014 | 05-16-2014 | Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-2267-20 | Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution | Hospira Inc. / 45,448 vials | Class II | Terminated |
| D-1478-2014 | 05-15-2014 | Cubicin 700 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29083, Discard After 05/21/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 7 units | Class II | Ongoing |
| D-1456-2014 | 05-15-2014 | Desferal 2.5 gm/14 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28314, Discard After 05/22/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 6 units | Class II | Ongoing |
| D-1453-2014 | 05-15-2014 | Levofloxacin 750 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #29184, Discard After 05/28/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 7 units | Class II | Ongoing |
| D-1474-2014 | 05-15-2014 | Vancomycin 750 mg/150mL D5W,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28878, Discard After 05/16/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 16 units | Class II | Ongoing |
| D-1458-2014 | 05-15-2014 | Ceftriaxone 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, RX # 29038, Discard After 05/05/14, & 05/20/14; RX # 29204, Discard After 05/23/14; RX # 29161, Discard After 05/19/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 31 units | Class II | Ongoing |
| D-1471-2014 | 05-15-2014 | Tobramycin 300 mg/7.5 mL Syringe (for Neb), Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28503, Discard After 02/27/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 14 units | Class II | Ongoing |
| D-1476-2014 | 05-15-2014 | Cubicin 543 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29175, Discard After 05/21/14; Rx # 28830, Discard After 05/17/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 10 units | Class II | Ongoing |
| D-1467-2014 | 05-15-2014 | Cubicin 444 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29114, Discard After 05/13/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 1 unit | Class II | Ongoing |
| D-1470-2014 | 05-15-2014 | ANA Kit, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28838, Discard After 03/4/15 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 1 unit | Class II | Ongoing |
| D-1482-2014 | 05-15-2014 | Ceftriaxone 1 gm/50 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29190, Discard After 05/23/14, Rx # 29068, Exp 05/18/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 12 units | Class II | Ongoing |
| D-1454-2014 | 05-15-2014 | Vancomycin 750 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28289, Discard After 02/5/14; Rx # 29189, Discard After 05/23/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 22 units | Class II | Ongoing |
| D-1455-2014 | 05-15-2014 | Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29183, Discard After 05/21/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 7 units | Class II | Ongoing |
| D-1465-2014 | 05-15-2014 | Impipenem/Cilastin (Primaxin) 500 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #28694, Discard After 05/22/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 21 units | Class II | Ongoing |
| D-1477-2014 | 05-15-2014 | Cubicin 600 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29096, Discard After 05/20/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 8 units | Class II | Ongoing |
| D-1481-2014 | 05-15-2014 | Cefepime 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28879, Discard After 05/21/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 11 units | Class II | Ongoing |
| D-1466-2014 | 05-15-2014 | Cefazolin 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28837, Discard After 04/11/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 21 units | Class II | Ongoing |
| D-1472-2014 | 05-15-2014 | Vancomycin 1 gm/100 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29186, Discard After 05/22/14; Rx # 29010, Discard After 05/22/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 21 units | Class II | Ongoing |
| D-1475-2014 | 05-15-2014 | Vancomycin 1.25 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29185, Discard After 05/23/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 14 units | Class II | Ongoing |
| D-1469-2014 | 05-15-2014 | Ambisome 285 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28300, Discard After 02/7/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 7 units | Class II | Ongoing |
| D-1468-2014 | 05-15-2014 | Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28839, Discard After 05/5/15; Rx # 29163, Discard After 05/8/15 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / | Class II | Ongoing |
| D-1457-2014 | 05-15-2014 | Cefepime 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28288, Discard After 02/4/14; Rx # 29176, Discard After 05/21/14; Rx # 28829, Discard After 05/17/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 24 units | Class II | Ongoing |
| D-1463-2014 | 05-15-2014 | Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29082, Discard After 05/19/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 60 units | Class II | Ongoing |
| D-1464-2014 | 05-15-2014 | Desferal 2 gm/8 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 27767, Discard After 05/23/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 2 units | Class II | Ongoing |
| D-1479-2014 | 05-15-2014 | Cefepime 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29011, Discard After 05/21/14, Rx # 29141, Discard After 05/22/14, Rx # 29171, Discard After 05/20/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 52 units | Class II | Ongoing |
| D-1460-2014 | 05-15-2014 | Invanz (ertapenem)1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29157, Discard After 05/19/14; Rx # 29097, Discard After 05/20/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 12 units | Class II | Ongoing |
| D-1480-2014 | 05-15-2014 | Ceftriaxone 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29150, Discard After 05/17/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 5 units | Class II | Ongoing |
| D-1459-2014 | 05-15-2014 | Cubicin 486 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, RX # 29038, Discard After 05/20/2014 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 7 | Class II | Ongoing |
| D-1461-2014 | 05-15-2014 | Meropenem 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29087, Discard After 05/28/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 42 units | Class II | Ongoing |
| D-1473-2014 | 05-15-2014 | Vancomycin 1.25 gm/250 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29140, Discard After 05/23/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 14 units | Class II | Ongoing |
| D-1462-2014 | 05-15-2014 | Nafcillin 12 gm/300 mL, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29162, Discard After 05/21/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 5 units | Class II | Ongoing |
| D-1347-2014 | 05-14-2014 | Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distributed by: OASIS, OASIS Medical, Inc., Glendora, CA 91741. UPC: 8 54819 00002 3. | Labeling: Missing Label; The label on the immediate bottle is missing. | Oasis Medical Inc / 10,549 Bottles | Class III | Terminated |
| D-1393-2014 | 05-12-2014 | MIC PLUS B12, Adenosine, L-Carnitine, Contains: Methionine 15mg, Choline 100mg, Inositol 50mg, B 12, 0.200mg, Adenosine 20mg, L-Carnitine 30mg/ML, 30ML MULTI DOSE VIAL, BENZYL ALCOHOL AS A PRESERVATIVE, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc / 210 mL | Class II | Terminated |
| D-1391-2014 | 05-12-2014 | Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL Vial, JOHN HOLLIS Pharmacist Inc, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc / 550 mL | Class II | Terminated |
| D-1403-2014 | 05-12-2014 | Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203 615-327-3234 | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc / 40 mL | Class II | Terminated |
| D-1388-2014 | 05-12-2014 | Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc / 300 mL | Class II | Terminated |
| D-1399-2014 | 05-12-2014 | Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc / 45 mL | Class II | Terminated |
| D-1405-2014 | 05-12-2014 | PYRIDOXINE HCL, Pyridoxine HCl 100mg, Also Contans: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc / 30 mL | Class II | Terminated |
| D-1397-2014 | 05-12-2014 | Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc / 365 mL | Class II | Terminated |
| D-1401-2014 | 05-12-2014 | Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc / 10 mL | Class II | Terminated |
| D-1394-2014 | 05-12-2014 | Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Water for Injection, Chlorobutanol USP, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc / 2250 mL | Class II | Terminated |
| D-1402-2014 | 05-12-2014 | Papaverine HCl 30 mg, Phentolamine Mesylate 0.5 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc / 25 mL | Class II | Terminated |
| D-1398-2014 | 05-12-2014 | B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate 0.03g, Choline Chloride 0.01g, Cyanocobalamin 0.3mg, Inositol 0.05g, Methionine 0.015g, Levocarnitine 0.1g, Chromic Chloride 0.15g, Lidocaine HCl 0.01g, Pyrodoxine HCl 0.005g, 30 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc / 30 mL | Class II | Terminated |
| D-1406-2014 | 05-12-2014 | Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth 9) 10 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 B2 Avenue N, Nashville, TN 37203, 615-327-3234 | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc / 100 mL | Class II | Terminated |
| D-1595-2014 | 05-12-2014 | COUMADIN FOR INJECTION (Warfarin Sodium for Injection, USP 5 mg Single-Use Vial Rx Only Distributed by Bristol Meyers Squibb Company, Princeton, NJ 08543 USA NDC 0590-0324-96 | Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials | Bristol-Meyers Squibb / 50,724 Vials | Class I | Terminated |
| D-1400-2014 | 05-12-2014 | Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc / 170 mL | Class II | Terminated |
| D-1390-2014 | 05-12-2014 | CYANOCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Each mL contains: Cyanocobalamin 1000 mcg, , Also Contains: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc / 2650 mL | Class II | Terminated |
| D-1404-2014 | 05-12-2014 | LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Riboflavin-5 phosphate 5mg, Niacinimide 50mg, Calcium Pantothenate 5 mg, Cyanocobalamin 1mg, Methionine 12.5mg, Choline 25mg, Inositol 25 mg, Sterile Water For injection, JOHN HOLLIS Pharmacist, Inc,110 20th Avenue N, Nashville, TN 37203, 615-327-3234 | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc / 80 mL | Class II | Terminated |
| D-1389-2014 | 05-12-2014 | Liver Derivative Complex for injection, each mL contains: Liver Derivative Complex 25.5mg, also contains: Water for Injection, Phenol 0.5%, HCl or NaOH to adjust pH, 10 mL, Compounded by Prescription: JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc / 1560 mL | Class II | Terminated |
| D-1395-2014 | 05-12-2014 | Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile Water for Injection and Benzyl Alcohol pH adjusted with HCl, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc / 1750 mL | Class II | Terminated |
| D-1550-2014 | 05-12-2014 | 0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL 60015 | Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes | Baxter Healthcare Corp. / 4,200 containers | Class I | Terminated |
| D-1348-2014 | 05-12-2014 | Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharmaceutica NV, Belgium, Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, NDC 0456-1420-30 Package NDCs: 0456-1402-30; 0456-1402-90; 0456-1402-01; 0456-1402-63; 0456-1405-30; 0456-1405-90; 0456-1405-01; 0456-1405-63; 0456-1410-30; 0456-1410-90; 0456-1410-01; 0456-1410-63; 0456-1420-30; 0456-1420-90; 0456-1420-01; 0456-1420-63 | Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life. | Forest Pharmaceuticals Inc / 21,875 bottles | Class II | Terminated |
| D-1396-2014 | 05-12-2014 | METHYLCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Methylcobalamin 1000 mcg, Also Contains: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc / 60 mL | Class II | Terminated |
| D-1392-2014 | 05-12-2014 | Testosterone Cypionate for Injection, each mL contains Testosterone Cypionate 200 mg, also contains: Cotton Seed Oil, Benzyl Benzoate, Benzyl Alcohol, Rx Only, 10 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc / 50 mL | Class II | Terminated |
| D-1342-2014 | 05-08-2014 | PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01 Package NDCs: 68382-040-01; 68382-040-05; 68382-040-10; 68382-041-01; 68382-041-05; 68382-041-10; 68382-042-01; 68382-042-05; 68382-042-10 | Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles. | Zydus Pharmaceuticals USA Inc / 10,200 bottles | Class II | Terminated |
| D1612-2014 | 05-05-2014 | AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City. | Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil. | Eugene Oregon, Inc. / 460 boxes | Class I | Terminated |
| D-1613-2014 | 05-05-2014 | Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang Pharmaceutical Co., Ltd. | Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil. | Eugene Oregon, Inc. / 136 boxes | Class I | Terminated |
| D-1614-2014 | 05-05-2014 | MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663 | Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil. | Eugene Oregon, Inc. / 57 boxes | Class I | Terminated |
| D-1434-2014 | 05-05-2014 | Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA | Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number | Axcentria Pharmaceuticals, LLC / 20,369 bottles | Class II | Terminated |
| D-1429-2014 | 05-02-2014 | Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10 Package NDCs: 63323-403-01; 63323-403-02; 63323-403-04; 63323-403-10 | Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials. | Fresenius Kabi USA, LLC / 728,880 vials | Class II | Terminated |
