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-1168-2016 | 05-13-2016 | B-COMPLEX #3 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 380 mL in Vials | Class II | Terminated |
| D-1246-2016 | 05-13-2016 | THIAMINE 100 MG/ML, 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1000 mL in Vials | Class II | Terminated |
| D-1193-2016 | 05-13-2016 | HYDROXY B12 1000MCG/ML IN NACL 0.9% (PF), 1ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 300 mL in Vials | Class II | Terminated |
| D-1182-2016 | 05-13-2016 | EDTA DISODIUM 15% (150MG/ML), 20ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 24000 mL in Vials | Class II | Terminated |
| D-1245-2016 | 05-13-2016 | TESTOSTERONE CYP 50 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML Vials, and e) 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 150 mL in Vials | Class II | Terminated |
| D-1219-2016 | 05-13-2016 | METHYL B12 10MG/ML W/PRES (BENZALKONIUM 0.01%) IN NACL 0.9%, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 331 mL in Vials | Class II | Terminated |
| D-1204-2016 | 05-13-2016 | LIPO B CYANO 1MG/ML W/PRES. (BENZYL ETOH 1%) METHIONINE 25MG, INOSITOL 50MG, CHOLINE CHL-50MG, CYANO B-12-100MCG, BENZYL ALCOHOL 1%/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 155 mL in Vials | Class II | Terminated |
| D-1223-2016 | 05-13-2016 | M.I.C B-COMPLEX W/PRES. (BENZYL ETOH 2%) B1-50MG;B2-5-PO4-5MG;B3-50MG;B5-5MG;B6-5MG; CYANO B12 100MCG; CHOLINE CHL-50MG; INOSITOL-25MG;METHIONINE 12.5MG/ML, 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1430 mL in Vials | Class II | Terminated |
| D-1244-2016 | 05-13-2016 | TESTOSTERONE CYP 25 MG/ML W/PRES (BENZYL ETOH 2%), 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 13 mL in Vials | Class II | Terminated |
| D-1178-2016 | 05-13-2016 | DEXPANTHENOL 250MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 3500 mL in Vials | Class II | Terminated |
| D-1248-2016 | 05-13-2016 | TMG 100 MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 85 mL in Vials | Class II | Terminated |
| D-1253-2016 | 05-13-2016 | ZINC SO4 1MG/ML (PF), 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 500 mL in Vials | Class II | Terminated |
| D-1195-2106 | 05-13-2016 | L-CARNITINE 50MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 2000 mL in Vials | Class II | Terminated |
| D-1234-2016 | 05-13-2016 | PYRIDOXAL 50 MG/THIAMINE 50 MG/LIDOCAINE 1% NS (PF), 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1000 mL in Vials | Class II | Terminated |
| D-1216-2016 | 05-13-2016 | METHYL B12 10MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1000 mL in Vials | Class II | Terminated |
| D-1236-2016 | 05-13-2016 | PYRIDOXINE HCL 100MG/ML W/PRES (BENZYL ETOH 0.02%), 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 4000 mL in Vials | Class III | Terminated |
| D-1230-2016 | 05-13-2016 | NANDROLONE DEC 200MG/ML W/PRES. (BENZYL ETOH 10%), In a) 2ML Vials, b) 4ML Vials, and c) 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 400 mL in Vials | Class II | Terminated |
| D-1181-2016 | 05-13-2016 | DMSO 99.9 (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 2218 mL in Vials | Class II | Terminated |
| D-1254-2016 | 05-13-2016 | HCL 2MG/ML (PF), 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1000 mL in Vials | Class II | Terminated |
| D-1208-2016 | 05-13-2016 | LIPO-INJECTION W/METHYL B12 500 MCG/CARNITINE/NO VIT C W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, CARNITINE 25MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 7000 mL in Vials | Class II | Terminated |
| D-1199-2016 | 05-13-2016 | L-PHENYLALANINE 15MG/ML (PF), 50ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 55 mL in Vials | Class II | Terminated |
| D-1227-2016 | 05-13-2016 | MOLYBDENUM 250MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1000 mL in Vials | Class II | Terminated |
| D-1173-2016 | 05-13-2016 | B-COMPLEX 50 IN NACL 0.9% W/PRES., (BENZYL ETOH 2%), B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 4000 mL in Vials | Class II | Terminated |
| D-1202-2016 | 05-13-2016 | LIPO #4 W/METHYL B12 500 MCG/ML/NO METHIONINE W/PRES (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;B3-30MG; B5-5MG;B6-5MG;METHYL B12 500 MCG; LIDOCAINE 10 MG; INOSITOL-25MG; CHOLINE CHL-25 MG/ML; 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1000 mL in Vials | Class II | Terminated |
| D-1188-2016 | 05-13-2016 | HYALURONIDASE 500U/ML(PF), 3ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 500 mL in Vials | Class II | Terminated |
| D-1240-2016 | 05-13-2016 | TAURINE 50 MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 10 mL in Vials | Class II | Terminated |
| D-1250-2016 | 05-13-2016 | ZINC CHLORIDE 10MG/ML IN NACL 0.29% (PF), 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 500 mL in Vials | Class II | Terminated |
| D-1203-2016 | 05-13-2016 | LIPO-INJECTION W/LIDOCAINE (PF), ASCORBIC ACID 50MG; B1-50MG; B2-5-PO4-5MG; B3-50MG B5-5MG, B6-5MG, CYANO B-12-100MCG, METHIONINE 12.5 MG, INOSITOL 25 MG, CHOLINE CL-25 MG, LIDCAINE 10 MG/ML, 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1000 mL in Vials | Class II | Terminated |
| D-1184-2016 | 05-13-2016 | FOLIC ACID 10MG/ML IN NACL (PF), 1ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 250 mL in Vials | Class II | Terminated |
| D-1172-2016 | 05-13-2016 | B-COMPLEX 50 IN NACL 0.9% (PF) B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1000 mL in Vials | Class II | Terminated |
| D-1171-2016 | 05-13-2016 | B-COMPLEX WITHOUT B12 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 955 mL in Vials | Class II | Terminated |
| D-1252-2016 | 05-13-2016 | ARGININE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1000 mL in Vials | Class II | Terminated |
| D-1190-2016 | 05-13-2016 | HYDROXY B12 5MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 210 mL in Vials | Class II | Terminated |
| D-1191-2016 | 05-13-2016 | HYDROXY B12 5MG/ML IN NACL 0.9% (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 800 mL in Vials | Class II | Terminated |
| D-1215-2016 | 05-13-2016 | METHYL B12 1000MCG/ML/PYRIDOXINE 100MG W/PRES. (BENZALKONIUM 0.01%), In a) 1ML Vials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 20 mL in Vials | Class II | Terminated |
| D-1231-2016 | 05-13-2016 | NIACINAMIDE 100 MG/ML (PF), In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 104 mL in Vials | Class II | Terminated |
| D-1214-2016 | 05-13-2016 | METHYL B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01% IN NACL 0.9%, In a) 2ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 8020 mL in Vials | Class II | Terminated |
| D-1209-2016 | 05-13-2016 | LIPO-INJECTION W/LIDOCAINE NO METHIONINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG,INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE-10MG/ML, 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 4000 mL in Vials | Class II | Terminated |
| D-1183-2016 | 05-13-2016 | ESTRADIOLVAL 3MG/TEST CYP 35MG/ TEST PROP 35MG/ML W/PRES. (BENZYL ETOH 2%), 3ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 10 mL in Vials | Class II | Terminated |
| D-1176-2016 | 05-13-2016 | CALCIUM SODIUM EDTA 300MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 8500 mL in Vials | Class II | Terminated |
| D-1175-2016 | 05-13-2016 | B-COMPLEX W/METHYL B12/LIDO W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, LIDOCAINE 1%, METHYL B12 1MG/ML, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 370 mL in Vials | Class II | Terminated |
| D-1167-2016 | 05-13-2016 | B-COMPLEX #3 (PF), B1-100MG, B2-2-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1000 mL in Vials | Class II | Terminated |
| D-1177-2016 | 05-13-2016 | CESIUM CHLORIDE 600MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 506 mL in Vials | Class II | Terminated |
| D-1238-2016 | 05-13-2016 | SELENIUM 200MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 884 mL in Vials | Class II | Terminated |
| D-1192-2016 | 05-13-2016 | HYDROXY B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01%), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 7000 mL in Vials | Class II | Terminated |
| D-1247-2016 | 05-13-2016 | THIAMINE 100 MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 213 mL in Vials | Class II | Terminated |
| D-1220-2016 | 05-13-2016 | M.I.C. 25/50/50 (PF) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50MG/ML, In 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 187 mL in Vials | Class II | Terminated |
| D-1200-2016 | 05-13-2016 | LIDOCAINE 2% (PF) IN NACL, 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 147 mL in Vials | Class II | Terminated |
| D-1206-2016 | 05-13-2016 | LIPO-INJECTION W/METHYL B12 1 MG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-1MG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 2000 mL in Vials | Class II | Terminated |
| D-1179-2016 | 05-13-2016 | DEXPANTHENOL 250MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1110 mL in Vials | Class II | Terminated |
| D-1222-2016 | 05-13-2016 | M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG, B5 0.083MG, B6 0.083MG, CYANO B12 1.66MCG, METHIONINE 0.208MG, INOSITOL 0.416MG, CHOLINE CL 1.66MG/ML, 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 110 mL in Vials | Class II | Terminated |
| D-1228-2016 | 05-13-2016 | NA ASCORBATE 500MG/ML (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 157,500 mL in Vials | Class II | Terminated |
| D-1169-2016 | 05-13-2016 | B-COMPLEX (LIEBERMAN) IN NACL 0.9% (PF), B1-12.5MG, B2-5-PO4-10MG, B3-12.5MG, B5-12.5MG, B6-12.5MG/ML, 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 60 mL in Vials | Class II | Terminated |
| D-1237-2016 | 05-13-2016 | RIBOFLAVIN 10MG/ML (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 35 mL in Vials | Class II | Terminated |
| D-1251-2016 | 05-13-2016 | ZINC SO4 10MG/ML (PF), Vials 2ML, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 2000 mL in Vials | Class II | Terminated |
| D-1194-2016 | 05-13-2016 | L-CARNITINE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1400 mL in Vials | Class II | Terminated |
| D-1180-2016 | 05-13-2016 | DMPS 50MG/ML (PF), 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1000 mL in Vials | Class II | Terminated |
| D-1201-2016 | 05-13-2016 | LIPO W/LIDOCAINE #3 W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;D3-30MG; B5-5MG;B6-5MG;CYANO B12-1MG; METHIONINE 12.5MG; INOSITOL-25MG; CHOLINE CL-25 MG; LIDOCAINE 10MG/ML, In a) 5 ML Vials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 7000 mL in Vials | Class II | Terminated |
| D-1044-2016 | 05-13-2016 | Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10 | Chemical Contamination: Bottles may contain broken dessicants | Virtus Pharmaceuticals, Llc / 24,614 bottles | Class III | Terminated |
| D-0101-2017 | 05-12-2016 | Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box | Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements | SOS Telecom Inc. / N/A | Class I | Terminated |
| D-0104-2017 | 05-12-2016 | Super Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box. | Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements | SOS Telecom Inc. / N/A | Class I | Terminated |
| D-0102-2017 | 05-12-2016 | Ninja-X, 4200 mg, 1 capsule per pack, 24 single packs per box. | Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements | SOS Telecom Inc. / N/A | Class I | Terminated |
| D-0103-2017 | 05-12-2016 | Ginseng Power-X , 1800 mg, 1 capsule per pack , 24 single packs per box. | Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements | SOS Telecom Inc. / N/A | Class I | Terminated |
| D-1039-2016 | 05-11-2016 | tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057 | CGMP Deviations | Profarma Distributors LLC / 42 boxes (504 capsules) | Class II | Terminated |
| D-1042-2016 | 05-11-2016 | VERMOX Tablets 500 mg, 1-count box, UPC 501109900596 | CGMP Deviations | Profarma Distributors LLC / 254 boxes (254 tablets) | Class II | Terminated |
| D-1041-2016 | 05-11-2016 | VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619 | CGMP Deviations | Profarma Distributors LLC / 163 boxes (978 tablets) | Class II | Terminated |
| D-1043-2016 | 05-11-2016 | 1% Clotrimazol cream, 30 mg tube, UPC 501318644335 | CGMP Deviations | Profarma Distributors LLC / 79 boxes (79 tubes) | Class II | Terminated |
| D-1040-2016 | 05-11-2016 | tabcin NOCHE; Capsules,12-count box, UPC 501008485033 | CGMP Deviations | Profarma Distributors LLC / 31 boxes ( 372 capsules) | Class II | Terminated |
| D-1053-2016 | 05-11-2016 | aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube, ALOE VERA Liniment Topical Analgesic 8 fl oz. bottle, Manufactured by Coats International, Inc., the ALOE SOURCE SPORT Sport Thermogenic Eucalyptus Cream 1 fl oz. plastic bottle, Dallas, TX 75243, NDC 58826-704-08, UPC 732295704089 | CGMP Deviations | The Aloe Source / 577 (212 1 fl oz.. plastic bottles, 167 8 fl oz. plastic bottles, 198 8 fl oz. plastic tubes) | Class II | Terminated |
| D-1065-2016 | 05-10-2016 | Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvine, CA 92612. UPC 300238335159 | Failed Content Uniformity Specifications. | Allergan Sales, LLC / N/A | Class II | Terminated |
| D-0977-2016 | 05-10-2016 | Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762 | Labeling; Product Contains Undeclared API (Oxybenzone) | Bayer Health Care LLC / 37,512 bottles | Class II | Terminated |
| D-1064-2016 | 05-10-2016 | Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b) 100g (NDC 0023-8335-10) tubes, Allergan Inc, Irvine, CA 92612 | Failed Content Uniformity Specifications. | Allergan Sales, LLC / 17802 units | Class II | Terminated |
| D-1491-2016 | 05-09-2016 | Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06 Package NDCs: 68382-110-06; 68382-110-01 | Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches. | Zydus Pharmaceuticals USA Inc / 14,808 bottles | Class II | Terminated |
| D-1033-2016 | 05-06-2016 | Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01 | Presence of Particulate Matter: Cardboard | Hospira Inc. / | Class II | Terminated |
| D-1375-2016 | 05-05-2016 | 1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9998, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-998-95 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 1,527 bags | Class II | Terminated |
| D-1403-2016 | 05-05-2016 | 2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9195, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-195-50 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 105 bags | Class II | Terminated |
| D-1411-2016 | 05-05-2016 | 20 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8216, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-216-96 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 212 Medical Cassettes | Class II | Terminated |
| D-1389-2016 | 05-05-2016 | 2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8103, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-103-48 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 425 bags | Class II | Terminated |
| D-1425-206 | 05-05-2016 | 5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6257, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-257-20 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 2,713 syringes | Class II | Terminated |
| D-1401-2016 | 05-05-2016 | 2 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8108, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-108-02 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 90 bags | Class II | Terminated |
| D-1414-2016 | 05-05-2016 | 3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8180 (NDC 61553-180-52), 250 mL in 250 mL Hospira LifeCare Bag Service Code 2H8262 (NDC 61553-262-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8180 (NDC 61553-180-02), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 345 bags | Class II | Terminated |
| D-1363-2016 | 05-05-2016 | 0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI (Preservative Free) in 0.9%, 150 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9994 , Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-994-83 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 15 bags | Class II | Terminated |
| D-1412-2016 | 05-05-2016 | 20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8947, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-947-48 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 555 Medical Cassettes | Class II | Terminated |
| D-1415-2016 | 05-05-2016 | 3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8239 (NDC 61553-239-50), 250 mL in 250 Baxter Intravia Bag, Service Code 2K8239 (NDC 61553-239-02), 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8284 (NDC 61553-284-01), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 1,470 bags | Class II | Terminated |
| D-1429-2016 | 05-05-2016 | 5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 ml Hospira LifeCare Bag, Service Code 2H8477 (NDC 61553-477-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8477 (NDC 61553-477-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 445 bags | Class II | Terminated |
| D-1364-2016 | 05-05-2016 | 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service Code 2K8195, 100 ml in 150 ml Baxter Intravia Bag (NDC 61553-195-48), Service Code 2H8266, 250 ml in 250 ml Hospira LifeCare Bag NDC 61553-266-50), 100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8272(NDC 61553-272-52), 100 ml in 100 ml Yellow Smiths Medical Cassette Service Code 2K8941 (NDC 61553-941-48), 250 ml in 250 ml Baxter Intravia Bag (W/O Additive Cap) Service Code 3V8716, (NDC 61553-716-17), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 4,081 bags | Class II | Terminated |
| D-1367-2016 | 05-05-2016 | 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119-09), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8171(NDC 61553-171-37)150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8463 (NDC 61553-463-47), 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8931(NDC 61553-931-02), 400 ml in 500 mL Baxter Intravia Bag, Service Code 2N1119, (NDC 61553-119-84), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, ; | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 355 bags | Class II | Terminated |
| D-1376-2016 | 05-05-2016 | 1 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8919, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-0919-52 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 25 bags | Class II | Terminated |
| D-1423-2016 | 05-05-2016 | 5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride Service Code 2K8135 , NDC 61553-135-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8136 , NDC 61553-136-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8447 , NDC 61553-447-25 , 500 ml in 500 ml Baxter Intravia Bag ; Service Code 2K9135 , NDC 61553-135-10 , 350 ml in 500 ml Baxter Intravia Bag ; Service Code 2K9915 , NDC 61553-915-97 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 4J8136 , NDC 61553-136-97 , 250 ml in 250 ml Baxter Intravia Bag ; Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 3,474 bags | Class II | Terminated |
| D-1379-2016 | 05-05-2016 | 10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H9155, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 3614, NDC 61553-1552-52 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 750 bags | Class II | Terminated |
| D-1392-2016 | 05-05-2016 | 2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 130 mL in 150 mL Baxter Intravia Bag, Service Code, 2K9226 (NDC 61553-226-98), 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9294 (NDC 61553-0294-92), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 950 bags | Class II | Terminated |
| D-1369-2016 | 05-05-2016 | 0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl (Preservative Free), 150 mL in 150 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-713-95 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 140 bags | Class II | Terminated |
| D-1372-2016 | 05-05-2016 | 0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1488 (NDC 61553-488-11), 500 mL in 500 mL Baxter Intravia Bag, Service Code 2N1489 (NDC 61553-489-01)Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 866 bags | Class II | Terminated |
| D-1368-2016 | 05-05-2016 | 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; , Service Code 2H8120 , NDC 61553-120-50 , 250 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2H8243 , NDC 61553-243-54 , 200 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2K8120 , NDC 61553-120-09 , 400 ml in 500 ml Baxter Intravia Bag ; , Service Code 2K8243 , NDC 61553-243-37 , 200 ml in 250 ml Baxter Intravia Bag ; , Service Code 2K9120 , NDC 61553-120-03 , 500 ml in 500 ml Baxter Intravia Bag ; , Service Code 2N1120 , NDC 61553-120-84 , 400 ml in 500 ml Baxter Intravia Bag ; , Service Code 2N9619 , NDC 61553-619-97 , 250 ml in 250 ml Baxter Intravia Bag ; Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 2,874 bags | Class II | Terminated |
| D-1374-2016 | 05-05-2016 | 1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9232, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-032-95 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 361 bags | Class II | Terminated |
| D-1407-2016 | 05-05-2016 | 2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8297, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-297-02 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 380 bags | Class II | Terminated |
| D-1384-2016 | 05-05-2016 | 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6733, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-20 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 1,577 BD syringes | Class II | Terminated |
| D-1371-2016 | 05-05-2016 | 0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2T8317, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-317-52 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 325 Medical Cassettes | Class II | Terminated |
| D-1380-2016 | 05-05-2016 | 10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8142, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-142-02 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / N/A | Class II | Terminated |
| D-1391-2016 | 05-05-2016 | 2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9966, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-966-95 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 17,990 bags | Class II | Terminated |
