Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
| D-1428-2014 | 05-02-2014 | Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-02 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 / 2,070,500 vials | Class II | Terminated |
| D-1427-2014 | 05-01-2014 | Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41. Package NDCs: 0054-3120-41 | Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point | Boehringer Ingelheim Roxane Inc / 5364 bottles | Class II | Terminated |
| D-1408-2014 | 05-01-2014 | Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02. Package NDCs: 0555-0952-02; 0555-0953-02 | Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing. | Teva Pharmaceuticals USA / 9,882 bottles | Class II | Terminated |
| D-1534-2014 | 04-30-2014 | Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts Metabolism, Limits Fat Absorption, Increases Energy, Prevents lipid formation by limiting fat absorption 30 pills /Bottle, Distributed by: Bacai, INC. www.litefitusa.com | Marketed Without an Approved NDA/ANDA: Bacai, Inc. DBA Ky Duyen House is voluntarily recalling Lite Fit USA, lot 13165, due to undeclared sibutramine, making it an unapproved new drug. | Bacai Inc. Dba Ky Duyen House / 14,040 softgel capsules | Class I | Terminated |
| D-1316-2014 | 04-29-2014 | Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules, packaged in 10-count ampoules per box, Laboratories Roche Nicholas S.A., F-74240 Gaillard, - Tel.: 04 50 87 70 70, Fabricant : Produits Roche, 52, Bld du Parc, 92521 Neulilly -sur-Seine Cedex, barcode *3421357* | Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote. | Flawless Beauty LLC / unknown | Class II | Completed |
| D-1321-2014 | 04-29-2014 | Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219 | Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection. | Flawless Beauty LLC / unknown | Class II | Completed |
| D-1319-2014 | 04-29-2014 | Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable solution, 1500 mg/500 mg, packaged in 8-count vials, 8-count 5 mL vitamin C (ascorbic acid) solution diluent ampoules, and 30-count Advanced Glutathione Boosters capsules per box, Relumins Labs, 183 Locust Avenue, West Long Branch, NJ 07764, UPC 700175760302 | Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims. | Flawless Beauty LLC / unknown | Class II | Completed |
| D-1318-2014 | 04-29-2014 | Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box, Exclusively Distributed by: QAF Pharmaceuticals Inc. Philippines, Unit Unit 202 ECG Building, Multinational Avenue, Multinational Village, Parahaque City, Metro Manila Philippines; Manufactured by: Shandong Luye Pharmaceutical Co. Ltd, Yantai Shandong, PRC la Luye Pharma Subsidiary, UPC 6920425209014 | Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote. | Flawless Beauty LLC / unknown | Class II | Completed |
| D-1320-2014 | 04-29-2014 | Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules per box, Manufactured by: TP Drug Laboratories (1969) Co., Ltd., 98 Soi Sukhumvlt 62, Yak 1, Bangchak, Prakanong, Bangkok 10260, Thailand, Reg. No. 1 A 1557/30; UPC 8 853533 000533 | Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease. | Flawless Beauty LLC / unknown | Class II | Completed |
| D-1317-2014 | 04-29-2014 | Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, 1200 mg/200 mg, 10-count vials per box, Manufactured by: Sujie Pharmaceutical Ltd., Tokyo, Japan, UPC 4973430081576 | Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote. | Flawless Beauty LLC / unknown | Class II | Completed |
| D-1349-2014 | 04-29-2014 | Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps per bottle (UPC 8 01650 02205 9) and b) 500-count VegeCaps per bottle (UPC 8 01650 02206 6), Manufactured by: Back to Health, Eugene, Oregon 97402. | Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement an unapproved new drug. | Independent Nutrition Center, Inc. / a) 209 bottles and b) 8 bottles | Class II | Terminated |
| D-1385-2014 | 04-28-2014 | TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel, Distributed by: Gate Pharmaceuticals div. of Teva Pharmaceuticals USA Sellersville,PA 18960. NDC 57844-713-46 | Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process. | Ferring Pharmaceuticals Inc / 129,060 cartons | Class II | Terminated |
| D-1352-2014 | 04-25-2014 | PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 mL), Distributed by Medtech Products, Inc., Tarrytown,NY ---- UPC 814832013544 | Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution | Prestige Brands Holdings / 12,269 cases/36 bottles | Class III | Terminated |
| D-1353-2014 | 04-25-2014 | PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and Phenylephrine HCl 2.5 mg) and NIGHTTIME MULTI-SYMPTOM Cold (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL oz (118 mL) bottles, one each of DAYTIME MULTI-SYMPTOM Cold, Distributed by Medtech Products, Inc., Tarrytown, NY --- UPC 814832013523 | Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution | Prestige Brands Holdings / 17,479 cases/12 dual packs | Class III | Terminated |
| D-1616-2014 | 04-24-2014 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6. Package NDCs: 0591-0397-60; 0591-0397-19; 0591-0398-60 | Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. | Actavis Laboratories, FL, Inc. / 36,538 bottles | Class II | Terminated |
| D-0293-2015 | 04-24-2014 | Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41. Package NDCs: 0338-5197-41 | Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers. | Baxter Healthcare Corp. / 19,152 Containers | Class II | Terminated |
| D-1617-2014 | 04-24-2014 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9. Package NDCs: 0591-0397-60; 0591-0397-19; 0591-0398-60 | Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. | Actavis Laboratories, FL, Inc. / 6,041 bottles | Class II | Terminated |
| D-1341-2014 | 04-23-2014 | QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 metered inhalations, packaged in an aluminum cylinder, Mktd. by: Teva Respiratory, LLC, Horsham, PA, Mfd. by: 3M Drug Delivery Systems, Northridge, CA. | Defective Delivery System; defective valve | Teva Pharmaceuticals USA / 461,592 canisters | Class II | Terminated |
| D-1344-2014 | 04-22-2014 | Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794-018-06, SigmaPharm Laboratories, LLC, Bensalem, Pa. Package NDCs: 42794-018-02; 42794-018-12; 42794-018-06; 42794-019-02; 42794-019-06; 42794-019-12; 42794-020-02; 42794-020-12 | Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product. | SigmaPharm Laboratories LLC / 43,007 Bottles | Class II | Terminated |
| D-1568-2014 | 04-21-2014 | Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78. | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Pharmakon Pharmaceuticals / 5 Syringes | Class I | Terminated |
| D-1567-2014 | 04-21-2014 | Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70. | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Pharmakon Pharmaceuticals / 200 Syringes | Class II | Terminated |
| D-1566-2014 | 04-21-2014 | Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48. | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Pharmakon Pharmaceuticals / 10/50 mL bags, 40/100 mL bags | Class I | Terminated |
| D-1565-2014 | 04-21-2014 | Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68. | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Pharmakon Pharmaceuticals / 20 vials | Class I | Terminated |
| D-1358-2014 | 04-21-2014 | Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10. 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. / 85,680 vials | Class I | Terminated |
| D-1282-2014 | 04-21-2014 | 0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0048-04. Package NDCs: 0338-0048-02; 0338-0048-03; 0338-0048-04; 0338-0048-05 | Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation. | Baxter Healthcare Corp. / 211,752 bottles | Class II | Terminated |
| D-0382-2015 | 04-18-2014 | 1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02. Package NDCs: 0409-4713-12; 0409-4713-26; 0409-4713-02; 0409-4713-72; 0409-4713-62; 0409-4713-75; 0409-4713-65; 0409-4713-42; 0409-4713-25; 0409-4713-32; 0409-4278-16; 0409-4278-01; 0409-4279-16; 0409-4279-02; 0409-4776-10; 0409-4776-01; 0409-4282-11; 0409-4282-25; 0409-4282-01; 0409-4282-12; 0409-4282-02; 0409-4277-16; 0409-4277-01; 0409-4277-17; 0409-4277-02; 0409-4276-16; 0409-4276-01; 0409-4276-17; 0409-4276-02; 0409-4275-16; 0409-4275-01 | Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution. | Hospira Inc. / 120,900 vials | Class I | Terminated |
| D-1609-2014 | 04-18-2014 | Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03 | Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point. | Apotex Corp. / 5,397 bottles | Class III | Terminated |
| D-0304-2015 | 04-17-2014 | Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA . | Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point. | Wockhardt Usa Inc. / 1,118,400 extended release tablets | Class III | Terminated |
| D-1544-2014 | 04-17-2014 | Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872, NDC 13811-558-30, UPC 3 13811 55830 2. | Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the formulation of this product does not contain Vitamin B12. | Trigen Laboratories, Inc. / 142,732 bottles | Class III | Terminated |
| D-1382-2014 | 04-17-2014 | CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6. | Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard. | Cubist Pharmaceuticals, Inc. / 51,500 vials | Class I | Terminated |
| D-1409-2014 | 04-16-2014 | Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-1211-30 Package NDCs: 0008-1211-50; 0008-1211-01; 0008-1211-14; 0008-1211-30; 0008-1222-01; 0008-1222-14; 0008-1222-30; 0008-1222-50; 0008-1210-30 | Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq. | Pfizer Us Pharmaceutical Group / 220,761 bottles | Class II | Terminated |
| D-1298-2014 | 04-15-2014 | Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl oz Bottles, liquid. Labeled A) aaron health KIDS, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262. UPC: 7 15256 72204 9. B) FAMILY wellness, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105. UPC: 0 32251 03394 0. C) Good Neighbor Pharmacy. Distributed By: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087. NDC: 24385-121-25. D) Pedia Care. Distributed by Medtech Products Inc., Irvington, NY 10533. UPC: 8 14832 01354 7. E) Quality Choice. Distributed by Quality Choice, Novi, MI 48376-0995. NDC: 63868-0368-04. F) Safeway. Distributed by Safeway Inc. P.O. Box 99, Pleasanton, CA 94566. NDC: 21130-152-04. G) Well at Walgreens. Distributed By: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0152-04. | Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution. | P&L Developments, LLC / 1,363,338 Bottles | Class III | Terminated |
| D-1535-2014 | 04-15-2014 | Super ARTHGOLD 500mg, 120 Capsule Bottle, Dietary Supplement. Manufactured for & Distributed by Nanowellbeing Health, Inc., 14747 Artesia Blvd, #5V, La Mirada, CA 90638. UPC: 7 99475 35350 5. | Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone. | Sung Soo Kim / 6,336 bottles | Class I | Terminated |
| D-1255-2014 | 04-14-2014 | Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Upsher-Smith Labs, Minneapolis, MN 55447, by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 0245-0272-06 | Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith. | Upsher Smith Laboratories, Inc. / 1,185 bottles | Class III | Terminated |
| D-1254-2014 | 04-14-2014 | Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6, 8, 10, and 12 oz Bottles, OTC Only. Labeled A) Aaron Health, 10 FL OZ, Manufactured by Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; B) Aaron Health, 8 FL OZ, Manufactured by: PL Developments, 11865 S. Alameda St, Lynwood, CA 90262, UPC: 7 15256 71428 0; C) Aaron Brands, 6 FL OZ, Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73506 3; D) Aaron Health, 4 FL OZ, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73504 9; E) Best Choice, 6 FL OZ, Proudly Distributed By: Valu Merchandisers, CO., Kansas City, MO 64111, UPC: 0 70038 61984 0 F) Best Choice, 10 FL OZ, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 61985; G) CareOne, 10 FL OZ, Distributed By American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31853 5; H) CareOne, 12 FL OZ, Distributed By: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31832 0; I) drug mart, 10 FL OZ, Distributed By: Discount Drug Mart-Food Fair, Medina, Ohio 44256, NDC: 93351-0142-1; J) DR, 6 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04479; K) DR, 10 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04480 6; L) equate, 10 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-01; M) equate: 12 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-02; N) exchange select, 10 FL OZ, Manufactured For: Your Military Exchanges, By Aaron Industries Inc., P.O. Box 801, Lynwood CA 90262, UPC: 6 14299 40234 8; O) Family wellness, 10 FL OZ, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105 USA, UPC: 0 32251 00504 6; P) Fred's, 10 FL OZ, Distributed By: Fred's, Inc., 4300 New Getwell Rd, Memphis, TN 38118, UPC: 0 84579 11020 9; Q) Laura Lynn, 6 FL OZ, Distributed by: Ingles Markets, Asheville, NC 28816, UPC: 0 86854 04767 5; R) LiveBetter, 10 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 49580-3416-1; S) LiveBetter, 6 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 41310-0142-6; T) Marc's, 10 FL OZ, Distributed by: Marc Glassman Inc. Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; U) 666 COLD Preparation, 4 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00224 3; V) 666 COLD Preparation, 8 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00228 1; W) Our Family, 12 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 97109 9; X) Our Family, 10 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 96745 0; Y) Premier Value, 6 FL OZ, Distributed By: Chain Drug Consortium, LLC., 2300 NW Corporate Blvd., Suite 115, Boca Rataon, FL 33431, NDC: 68016-0023-79; Z) Premier Value, 8 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-08; AA) Premier Value, 10 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-01; BB) Publix, 10 FL OZ, Distributed By: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, 0 41415 27073 2; CC) Quality Choice, 8 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novi, MI 48376, NDC: 63868-245-08; DD) Quality Choice, 10 FL OZ, Distributed by Quality Choice, Novi, MI 48376, NDC: 63868-0245-10; EE) Quality Choice, 12 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novli, MI 48376, NDC: 63868-245-12; FF) Rite Aid, 6 FL OZ, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 170 | Subpotent Drug: Phenylephrine component is subpotent. | P&L Developments, LLC / 2,500,510 bottles | Class III | Terminated |
| D-0247-2015 | 04-14-2014 | HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01 Package NDCs: 63323-469-01; 63323-469-05; 63323-471-01; 63323-471-05 | Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result. | Fresenius Kabi USA LLC / 216,517 vials | Class III | Terminated |
| D-1357-2014 | 04-14-2014 | LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactured by Arrow Pharm (Malta) Ltd., Bizebbugia, Malta, Packaged by GSMS, Inc. Camarillo, CA --- NDC 60429-317-30 | Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning | Golden State Medical Supply Inc. / 6,042 bottles | Class II | Terminated |
| D-1343-2014 | 04-14-2014 | phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 02451, NDC 0781-2081-02 | Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepressant.. | Fresenius Medical Care Holdings, Inc. / 14,496 bottles | Class II | Terminated |
| D-1286-2014 | 04-11-2014 | Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg (Cough Suppressant) , Guaifenesin, USP, 200 mg (Expectorant), 4, 8 fl oz bottles , OTC only, labeled as A) CareOne 8 fl oz bottle, Distributed by American Sales Company, Lancaster, NY 14086, UPC 341520339677, B) Our Family 4 fl oz bottle, Distributed by Nash Finch Company, NFC Brands, MPLS, MN 55435, UPC 070253579523, C) Premier Value 4, 8 fl oz bottle, Distributed by Chain Drug Consortium, LLC., Boca Raton, FL 33431, 4 fl oz UPC 840986024719; 8 fl oz UPC 840986024726, NDC 68016-177-XX, D) Rexall 4 fl oz bottle, Packaged for Dolencorp, LLC, Goodlettsville, TN 37072, UPC 715256714044, E) Safeway 4 fl oz, Distributed by Safeway INC, Pleasanton, CA 94566-0009, UPC 321130763581; F) Select Brand 4, 8 fl oz, Distributed by Select Brand Distributers, Pine Bluff, AR 71603, 4 fl oz UPC 015127024303; 8 fl oz UPC 015127024310. | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. | Aaron Industries Inc / 108,792 bottles | Class III | Terminated |
| D-1411-2014 | 04-10-2014 | Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-5315-38, UPC 3 09045 31538 5. | Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye. | Bausch & Lomb, Inc. / 35,253 tubes | Class II | Terminated |
| D-1355-2014 | 04-10-2014 | Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02. | Failed Dissolution Specifications: Failure of dissolution test observed at three month time point. | Wockhardt Usa Inc. / 8712 Bottles | Class II | Terminated |
| D-1410-2014 | 04-10-2014 | Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sample, NDC 24208-385-01, UPC 3 24208-385-01 2; b) 1/8 oz. (3.5 g) tube per carton, NDC 24208-385-55, UPC 3 24208-385-55 5; and c) 1/4 oz. (7 g) Twin Pack, Two 1/8 oz. (3.5 g) tubes per carton, NDC 24208-385-56, UPC 3 24208-385-56 3; Bausch & Lomb Incorporated, Tampa, FL 33637. Package NDCs: 24208-385-55; 24208-385-56; 24208-385-01 | Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye. | Bausch & Lomb, Inc. / a) 4,165 tubes; b) and c) 844,879 tubes | Class II | Terminated |
