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-1230-2015 | 06-01-2015 | Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11); 5 blister packs per carton (NDC 68084-008-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. | CGMP Deviations: Firm did not adequately investigate customer complaints. | American Health Packaging / 5,416 cartons | Class II | Terminated |
| D-1229-2015 | 06-01-2015 | Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11); 10 blister packs per carton (NDC 68084-064-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. | CGMP Deviations: Firm did not adequately investigate customer complaints. | American Health Packaging / 1,516 cartons | Class II | Terminated |
| D-1222-2015 | 06-01-2015 | Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464-11); 3 blister packs per carton (NDC 68084-464-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. | CGMP Deviations: Firm did not adequately investigate customer complaints. | American Health Packaging / 838 cartons | Class II | Terminated |
| D-1227-2015 | 06-01-2015 | Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11); 10 blister packs per carton (NDC 68084-061-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. | CGMP Deviations: Firm did not adequately investigate customer complaints. | American Health Packaging / 13,532 cartons | Class II | Terminated |
| D-1224-2015 | 06-01-2015 | Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5 blister packs per carton (NDC 68084-279-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. | CGMP Deviations: Firm did not adequately investigate customer complaints. | American Health Packaging / 3,572 cartons | Class II | Terminated |
| D-1223-2015 | 06-01-2015 | Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278-11); 10 blister packs per carton (NDC 68084-278-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. | CGMP Deviations: Firm did not adequately investigate customer complaints. | American Health Packaging / 2,068 cartons | Class II | Terminated |
| D-1220-2015 | 06-01-2015 | Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-506-11); 10 blister packs per carton (NDC 68084-506-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. | CGMP Deviations: Firm did not adequately investigate customer complaints. | American Health Packaging / 1,745 cartons | Class II | Terminated |
| D-1218-2015 | 06-01-2015 | Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC 68084-498-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. | CGMP Deviations: Firm did not adequately investigate customer complaints. | American Health Packaging / 1,896 cartons | Class II | Terminated |
| D-1214-2015 | 05-29-2015 | Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3161-9 | Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. | Apotex Inc. / 23,076 bottles | Class II | Terminated |
| D-1213-2015 | 05-29-2015 | Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3162-9 | Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. | Apotex Inc. / 23,178 bottles | Class II | Terminated |
| D-1212-2015 | 05-29-2015 | Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3160-9 | Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. | Apotex Inc. / 45,708 bottles | Class II | Terminated |
| D-1215-2015 | 05-29-2015 | Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India, NDC 60505-0209-1 | Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. | Apotex Inc. / 4,584 bottles | Class II | Terminated |
| D-1167-2015 | 05-28-2015 | Vancomycin HCl in Dextrose, VANCOMYCIN 500mg / D5W 100mL AccuFlo, Qty: 12 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 12 Bags | Class II | Terminated |
| D-1188-2015 | 05-28-2015 | Vancomycin, VANCOMYCIN 750mg / NS 100mL AccuFlo, Qty: 7 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 7 Bags | Class II | Terminated |
| D-1175-2015 | 05-28-2015 | Fluorouracil 1200mg / D5W 274mL, Qty: 1 274 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1194-2015 | 05-28-2015 | Pfizerpen-G 4.2 MU / SW 240 mL AccuFlo, Packaged in 2 240 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assure | Lincare, Inc. / 2 Bags | Class II | Terminated |
| D-1158-2015 | 05-28-2015 | TPN 2:1, 200 ml Bags, Qty: 7, Base Formula NaCl 0.9%, Dextrose 70%, Trophamine 10%, Water for Inj; Electrolytes Calcium Gluc, MgSO4, Na Phos, KCL; Vitamins, trace elements and medications Copper Cl, Selenium, Zinc Sulfate, Infuvite Pediat, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 7 Bags | Class II | Terminated |
| D-1205-2015 | 05-28-2015 | Gentamicin Sulfate, GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Qty: 7 30 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 7 Syringes | Class II | Terminated |
| D-1174-2015 | 05-28-2015 | Fluorouracil 4800mg / D5W 296mL, Qty: 1 296 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1190-2015 | 05-28-2015 | Diphenhydramine HCl, Diphenhydramine 25mg / NS 10 ml syringe, Qty: 2 10 mL syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 2 Syringes | Class II | Terminated |
| D-1160-2015 | 05-28-2015 | TPN 3:1, 1440 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes Calcium Gluc, Na Phos, Na Acetate, MgSO4, K Acetate; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Folic Acid, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 7 Bags | Class II | Terminated |
| D-1186-2015 | 05-28-2015 | Vancomycin HCl / Heparin, Vancomycin 50mcg/ml / HEPARIN 100u/ml, Qty: 8, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 8 Units | Class II | Terminated |
| D-1164-2015 | 05-28-2015 | TPN 3:1, 1090 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes K Phos, KCL, MgSO4, NaCl, Ca Gluconate, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 7 Bags | Class II | Terminated |
| D-1192-2015 | 05-28-2015 | Vancomycin HCl/Heparin, Vancomycin 50mcg/mL / Heparin 100u/mL, Qty: 3, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 3 Units | Class II | Terminated |
| D-1177-2015 | 05-28-2015 | Fluorouracil 3200mg / D5W 264mL, Qty: 1 264 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1157-2015 | 05-28-2015 | TPN 3:1, 1800 ml Bags, Qty: 2, Base Formula NaCl 0.9%, Dextrose 70%, Travasol 10%, Intralipid 20%, Water; Electrolytes K Phos, Mag Sulfate, KCL, Ca Gluconate; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 2 Bags | Class II | Terminated |
| D-1173-2015 | 05-28-2015 | CEFTRIAXONE SODIUM 2000mg / NS 50mL, Qty:4 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 4 Bags | Class II | Terminated |
| D-1153-2015 | 05-28-2015 | TPN 3:1, 2250 mL Bags, Qty: 5, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, Intralipid 20%, Water for Inj; Electrolytes KCL, K Phos, Famotidine, Na Acetate, MgSO4; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 5 Bags | Class II | Terminated |
| D-1187-2015 | 05-28-2015 | Fentanyl Citrate, FENTANYL 25,000 MCG / 500 ML, Qty: 1 500 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1152-2015 | 05-28-2015 | TPN 3:1, 2400 mL Bag, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj.; Electrolytes KCL, K Acetate, Na Acetate, K Phos, MgSO4; Vitamins, trace elements and medications Trace Ele. -Ped, Multi Vitamin, Rx Only, Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 6 Bags | Class II | Terminated |
| D-1163-2015 | 05-28-2015 | TPN 3:1, 1050 mL Bags, Qty: 6, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes KCL, K Phos, MgSO4, NaCl, Zinc Cl, Ca Gluconate; Vitamins, trace elements and medications Trace Ele.-Ped, Infuvite Pediat, Carnitor, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 6 preparations | Class II | Terminated |
| D-1199-2015 | 05-28-2015 | Cefepime HCl, CEFEPIME 850 mg NS 50mL AccuFlo, Qty: 12 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 12 Bags | Class II | Terminated |
| D-1196-2015 | 05-28-2015 | Vancomycin 750 mg/NS 100 ml accuflo, Packaged in 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 2 Bags | Class II | Terminated |
| D-1161-2015 | 05-28-2015 | TPN 3:1, 1750 mL Bags, Qty: 5, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes Famotidine, KCL, K Phos, Na Acetate, MgSO4, NaCl; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Vitamin K, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 5 Bags | Class II | Terminated |
| D-1169-2015 | 05-28-2015 | CefTRIAXone Sodium, Ceftriaxone 1 gram / NS 50 mL, Qty: 10 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 10 Bags | Class II | Terminated |
| D-1172-2015 | 05-28-2015 | Vancomycin HCl in Dextrose, VANCOMYCIN 750mg / D5W 150mL, Qty: 6 150 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 6 Bags | Class II | Terminated |
| D-1178-2015 | 05-28-2015 | HYDROmorphone HCl PF, HYDROMORPHONE HCL 1000mg /NS 500mL, Qty: 1 500 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1204-2015 | 05-28-2015 | Ganciclovir Sodium, 250MG / NS 100ML, QTY: 6 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 6 Bags | Class II | Terminated |
| D-1166-2015 | 05-28-2015 | Penicillin G Potassium 5.4 MU/SW 240 mL AccuFlo, Qty: 4 240 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 4 Bags | Class II | Terminated |
| D-1201-2015 | 05-28-2015 | Ceftazidime 2 gm / NS 50mL, Qty: 15 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 15 Bags | Class II | Terminated |
| D-1203-2015 | 05-28-2015 | Fluorouracil 4250mg / D5W 285mL, Qty: 1 285 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1181-2015 | 05-28-2015 | VANCOMYCIN HCL 250mg / NS 6mL syringe, Packaged in 6 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / Unknown | Class II | Terminated |
| D-1193-2015 | 05-28-2015 | Cefepime HCl, Cefepime 2 gm / NS 100 mL AccuFlo, Qty: 14 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured | Lincare, Inc. / 14 Bags | Class II | Terminated |
| D-1179-2015 | 05-28-2015 | Vancomycin HCl in Dextrose, VANCOMYCIN 750mg / D5W 150mL, Qty: 12 150 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 12 Bags | Class II | Terminated |
| D-1171-2015 | 05-28-2015 | VANCOMYCIN 1.25gm / NS 250mL AccuFlo, Qty: 7 250 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 7 Bags | Class II | Terminated |
| D-1189-2015 | 05-28-2015 | Ceftriaxone Sodium, Ceftriaxone 2gm / NS 50mL, Qty: 12 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 12 Bags | Class II | Terminated |
| D-1191-2015 | 05-28-2015 | Vancomycin HCl, Vancomycin 1500mg / D5W 265mL, Qty: 2 265 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 2 Bags | Class II | Terminated |
| D-1165-2015 | 05-28-2015 | TPN 3:1, 1844 mL Bags, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, Intralipid 20%, Water for Inj; Electrolytes KCL, Ca Gluconate, MgSO4, K Phos; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 6 Bags | Class II | Terminated |
| D-1182-2015 | 05-28-2015 | VANC 50MCG/ML-HEP 100U/ML in 2ML, Packed in 2 mL Units, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / Unknown | Class II | Terminated |
| D-1198-2015 | 05-28-2015 | Potassium Chloride, Dextrose 5% LR 1000 mL with 40mEq KCL, Qty: 1 1000 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1155-2015 | 05-28-2015 | TPN 3:1, 997 ml with lipids Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Rx Only. United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 4 Bags | Class II | Terminated |
| D-1154-2015 | 05-28-2015 | TPN 3:1, 2000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes K Acetate, Na Acetate, Famotidine, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Salenium, Multi Vitamin, Vitamin K, Ascorbic Acid, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 7 Bags | Class II | Terminated |
| D-1162-2015 | 05-28-2015 | TPN 3:1, 817 mL Bags, Qty: 5, Base Formula Dextrose 70%, Trophamine 10%, Intralipid 20%, Water for Inj; Electrolytes K Phos, KCL, MgSO4, NaCl, Ca Gluconate; Vitamins, trace elements and medications Trace Ele.-Ped, Infuvite Pediat, Carnitor, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 5 Bags | Class II | Terminated |
| D-1197-2015 | 05-28-2015 | Vancomycin 1000mg / NS 100mL, Packaged in 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / Unknown | Class II | Terminated |
| D-1183-2015 | 05-28-2015 | DEFEROXAMINE MESYLATE 3gm / NS 240mL Accuflo, Packaged in 240 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / Unknown | Class II | Terminated |
| D-1176-2015 | 05-28-2015 | FLUOROURACIL 1560MG / D5W 281ML, Qty: 1 281 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1156-2015 | 05-28-2015 | TPN 3:1, 997 ml without lipids Bags, Qty: 3, Base Formula Dextrose 70%, Travasol 10%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Infuvitm Pediat, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 3 Bags | Class II | Terminated |
| D-1200-2015 | 05-28-2015 | Morphine Sulfate, MORPHINE SULFATE 1000mg / NS 100mL, Qty: 1 50 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1159-2015 | 05-28-2015 | TPN 3:1, 3000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes Famotidine, MgSO4, KCL, NaC, Zinc Cl; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Vitamin K, Ascorbic Acid, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 7 Bags | Class II | Terminated |
| D-1195-2015 | 05-28-2015 | GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Packaged in 30 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 2 Syringes | Class II | Terminated |
| D-1185-2015 | 05-28-2015 | CIPROFLOXACIN 400MG / D5W 200ML ACCUFLO, Packaged in 3 200 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 3 Bags | Class II | Terminated |
| D-1180-2015 | 05-28-2015 | Fluorouracil 4600mg / D5W 292 mL, Qty: 1 292 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1168-2015 | 05-28-2015 | Fluorouracil 5760mg / D5W 265mL Qty: 1 265 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1184-2015 | 05-28-2015 | CEFEPIME 1gm / NS 50mL AccuFlo, Packaged in 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 3 Bags | Class II | Terminated |
| D-1202-2015 | 05-28-2015 | HYDROmorphone HCl PF, Hydromorphone 1000 mg / NS 500 mL, Qty: 1 500 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1170-2015 | 05-28-2015 | Fluorouracil 1400mg / D5W 278mL Qty: 1 278 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. / 1 Bag | Class II | Terminated |
| D-1147-2015 | 05-27-2015 | E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-01 | Failed stability specifications:This recall has been initiated due to out of specification results for viscosity. | Bracco Diagnostic Inc / 1008 boxes | Class III | Terminated |
| D-1138-2015 | 05-22-2015 | Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured by: Novartis Pharma AG Basle,Via Serafino Balestra 31 Locarno, Switzerland. | Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing. | Novartis Pharmaceuticals Corp. / 55,442 packs | Class III | Terminated |
| D-1110-2015 | 05-22-2015 | Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-522-20, MFG: 64679-904-02 | cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure | Blenheim Pharmacal, Inc. / 50 bottles | Class II | Terminated |
| D-1137-2015 | 05-22-2015 | Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured by: Novartis Pharma AG Basle,Via Serafino Balestra 31 Locarno, Switzerland. | Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing. | Novartis Pharmaceuticals Corp. / 19,658 packs | Class III | Terminated |
| D-1109-2015 | 05-22-2015 | Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Packaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-175-30, MFG: 64679-904-02 | cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure | Blenheim Pharmacal, Inc. / 166 bottles | Class II | Terminated |
| D-0658-2016 | 05-22-2015 | Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject Barrel Syringes in Sodium Chloride 0.9%, Rx only, Contains Sulfites, Compounded Drug, Not for Resale, Hospital/Office Use only, IV use only, NDC 61553-401-44. | Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay. | Pharmedium Services, LLC / 19 Syringes | Class I | Terminated |
| D-1135-2015 | 05-22-2015 | Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India Package NDCs: 55111-533-30; 55111-533-60; 55111-533-01; 55111-533-05; 55111-533-79; 55111-533-78 | Failed Dissolution Specifications; exceeded specification at the 9 hour time point | Dr. Reddy's Laboratories, Inc. / 100 count 7479; 500 count - 2544 | Class II | Terminated |
| D-1136-2015 | 05-22-2015 | Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01 Package NDCs: 55111-534-30; 55111-534-60; 55111-534-01; 55111-534-05 | Failed Dissolution Specifications; exceeded specification at the 9 hour time point | Dr. Reddy's Laboratories, Inc. / 5,160 bottles | Class II | Terminated |
| D-1113-2015 | 05-21-2015 | SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight Pharmaceuticals, LLC, Trevose, PA 19053-8433 | Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey Lemon lozenges was applied to the underside of the Sucrets Sore Throat & Cough Vapor Cherry lozenges tin. | Medtech Products, Inc. / 107,832 tins | Class II | Terminated |
| D-1206-2015 | 05-21-2015 | CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen Therapeutics, Inc., La Jolia, CA 92037, Distributed by Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015, NDC 64764-890-99. | Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components. | Takeda Pharmaceuticals North America, Inc. / 3,619 bottles | Class II | Terminated |
| D-1111-2015 | 05-20-2015 | Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7. | Failed Dissolution Specifications: Low out of specification dissolution results. | Mylan Lab Inc / 7,722 bottles | Class II | Terminated |
| D-1232-2015 | 05-19-2015 | Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured by Hospira, Inc. 4285 Wesleyan Blvd Rocky Mount, NC 27804 for Hospira, Inc. 275 N Field Drive, Lake Forest, IL 60045. NDC 0409-2168-02 | Failed pH Specifications: 12 month stability testing | Hospira Inc. / 106,900 vials | Class III | Terminated |
| D-1106-2015 | 05-18-2015 | SODIUM TETRADECYL SULFATE (STERILE WATER) (30ML) 3.5% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 1 vial | Class II | Terminated |
| D-1102-2015 | 05-18-2015 | NANPYRIDOXINE (STERILE WATER) 30ML 50MG/ML INJECTABLE,Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 30 vials | Class II | Terminated |
| D-1099-2015 | 05-18-2015 | HYDROXYZINE HYDROCHLORIDE (30ML VIAL) (STERILE WATER) 50MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 3 vials | Class II | Terminated |
| D-1096-2015 | 05-18-2015 | GLUTATHIONE 200MG/ML (STERILE WATER) (30ML, 50ML VIAL) INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / | Class II | Terminated |
| D1091-2015 | 05-18-2015 | DMSO (STERILE WATER) SOLUTION -50ML VIAL 50% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 41 vials | Class II | Terminated |
| D-1094-2015 | 05-18-2015 | ESTRADIOL VALERATE (10ML VIAL) SESAME OIL 45MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 17 vials | Class II | Terminated |
| D1092-2015 | 05-18-2015 | ESTRADIOL CYPIONATE (SESAME OIL) (10ML, 30ML VIAL) 40MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 6 vials | Class II | Terminated |
| D-1101-2015 | 05-18-2015 | NANDROLONE DECANOATE (SESAME OIL) 100ML VIAL 200MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 32 vials | Class II | Terminated |
| D-1093-2015 | 05-18-2015 | ESTRADIOL CYPIONATE (SESAME OIL) 10ML, 30ML VIAL 5MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 21 vials | Class II | Terminated |
| D-1098-2015 | 05-18-2015 | HYDROXYPROGESTERONE CAPROATE (OLIVE OIL) 30ML, 10ML VIAL 250MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 28 vials | Class II | Terminated |
| D-1095-2015 | 05-18-2015 | ESTRADIOL VALERATE (SESAME OIL) 10ML VIAL 10MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 1 vial | Class II | Terminated |
| D-1107-2015 | 05-18-2015 | VITAMIN D3 (OLIVE OIL) (30ML VIAL) 50,000 UNITS/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 2 vials | Class II | Terminated |
| D-1105-2015 | 05-18-2015 | SODIUM TETRADECYL (STERILE WATER) 30ML VIAL 2% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 1 vial | Class II | Terminated |
| D-1097-2015 | 05-18-2015 | GLYCERIN (STERILE WATER) 100ML 71% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 1 vial | Class II | Terminated |
| D-1090-2015 | 05-18-2015 | CYANOCOBALAMIN (PARABEN WATER) (10ML, 30ML VIAL) 2000MCG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 77 vials | Class II | Terminated |
| D-1104-2015 | 05-18-2015 | SODIUM HYALURONATE (STERILE WATER) 2.5 ML VIAL 20MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 21 vials | Class II | Terminated |
| D-1103-2015 | 05-18-2015 | SODIUM HYALURONATE (2ML PREFILLED SYRINGE) STERILE WATER 20MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 416 syringes | Class II | Terminated |
| D-1100-2015 | 05-18-2015 | HYDROXYZINE HYDROCHLORIDE (STERILE WATER) (10ML VIAL) 25MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605 | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. / 2 vials | Class II | Terminated |
| D-1132-2015 | 05-15-2015 | MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37% Organically Bound Iodine For Gastrointestinal Radiography; Oral or rectal use only; Rx only; 30 mL; Single-Unit Container; ; Mallinckrodt Inc., St. Louis, MO 63042. NDC 0019-4816-04 Package NDCs: 0019-4816-04 | Labeling: incorrect or missing lot number and/or expiration date | Mallinckrodt, Inc. / 6600 bottles | Class II | Terminated |
| D-1122-2015 | 05-15-2015 | Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 10/3 mL vials | Class II | Terminated |
| D-1117-2015 | 05-15-2015 | Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 1/5mL vial | Class II | Terminated |
| D-1126-2015 | 05-15-2015 | Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy / 25/5 mL. vials | Class II | Terminated |
