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-0898-2018 | 06-14-2018 | Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT | Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. | SCA Pharmaceuticals, LLC / 2,268 bags | Class II | Terminated |
| D-0895-2018 | 06-14-2018 | Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT | Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. | SCA Pharmaceuticals, LLC / 492 bags | Class II | Terminated |
| D-0900-2018 | 06-14-2018 | Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT | Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. | SCA Pharmaceuticals, LLC / 1,397 bags | Class II | Terminated |
| D-0896-2018 | 06-14-2018 | Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT | Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. | SCA Pharmaceuticals, LLC / 179 bags | Class II | Terminated |
| D-0904-2018 | 06-14-2018 | Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT | Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. | SCA Pharmaceuticals, LLC / | Class II | Terminated |
| D-0903-2018 | 06-14-2018 | Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT | Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. | SCA Pharmaceuticals, LLC / 400 bags | Class II | Terminated |
| D-0897-2018 | 06-14-2018 | Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT | Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. | SCA Pharmaceuticals, LLC / 2,869 bags | Class II | Terminated |
| D-0899-2018 | 06-14-2018 | Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT | Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. | SCA Pharmaceuticals, LLC / 1,882 bags | Class II | Terminated |
| D-0902-2018 | 06-14-2018 | Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT | Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. | SCA Pharmaceuticals, LLC / 451 bags | Class II | Terminated |
| D-0907-2018 | 06-13-2018 | Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b) 238 g bottle (NDC 49035-312-08), Distributed by: Wal-mart Stores, Inc., Bentonville, AR 72716 | Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes. | LUPIN SOMERSET / 2,229,052 bottles | Class III | Terminated |
| D-0952-2018 | 06-12-2018 | MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 104 mL. Single dose bag. For: Desert Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-907-10 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 175 bags | Class II | Terminated |
| D-0928-2018 | 06-12-2018 | 0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose pump. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77056. NDC: 42852-661-02 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 40 pumps | Class II | Terminated |
| D-0932-2018 | 06-12-2018 | EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-823-25. | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 700 bags | Class II | Terminated |
| D-0929-2018 | 06-12-2018 | ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride (USP) 100mL. Volume 110 mL. Single dose bag. Avella of Houston 9265 Kirby Dr., Houston, TX 77054 NDC: 42852-604-10 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 2,500 bags | Class II | Terminated |
| D-0956-2018 | 06-12-2018 | Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. For: Coral Gables Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-408-10 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 220 bags | Class II | Terminated |
| D-0939-2018 | 06-12-2018 | NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (Concentration 32 mcg/mL) Volume: 258 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-815-25 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 4,280 bags | Class II | Terminated |
| D-0930-2018 | 06-12-2018 | ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-61 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 5400 syringes | Class II | Terminated |
| D-0936-2018 | 06-12-2018 | MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 108 mL. Single dose bag. For: Gaston Memorial Hospital By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-905-10 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 100 bags | Class II | Terminated |
| D-0951-2018 | 06-12-2018 | MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 102 mL. Single dose bag. For: Salt Lake Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-906-10 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 25 bags | Class II | Terminated |
| D-0964-2018 | 06-12-2018 | ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-895-61 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 225 syringes | Class II | Terminated |
| D-0965-2018 | 06-12-2018 | PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Volume: 251 mL Single dose bag. For: Redlands Community Hospital Pharmacy. BY: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 NDC 15082-856-25 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 40 bags | Class II | Terminated |
| D-0961-2018 | 06-12-2018 | NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-860-25 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 1290 bags | Class II | Terminated |
| D-0931-2018 | 06-12-2018 | EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-855-25. | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 420 bags | Class II | Terminated |
| D-0944-2018 | 06-12-2018 | fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacaine HCL PF, USP, 250 mg, 0.9% Sodium Chloride, USP QS 250 mL. Volume: 250mL. Single dose Cassette. For: Methodist St. John Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-250-87 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 15 cassettes | Class II | Terminated |
| D-0935-2018 | 06-12-2018 | HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 mL) Volume: 50mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-65 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 275 syringes | Class II | Terminated |
| D-0937-2018 | 06-12-2018 | Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston TX 77054. NDC 4252-401-10 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 1860 bags | Class II | Terminated |
| D-0940-2018 | 06-12-2018 | PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume: 254 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-893-25 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 200 bags | Class II | Terminated |
| D-0954-2018 | 06-12-2018 | MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS 30mL). Volume 30 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-243-63 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 740 syringes | Class II | Terminated |
| D-0947-2018 | 06-12-2018 | HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% Dextrose Inj., USP 250 mL) Volume: 252.5 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue Phoenix, AZ 85085. NDC 42852-745-25 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 900 bags | Class II | Terminated |
| D-0945-2018 | 06-12-2018 | fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10 mcg per mL) 5 mcg in 0.5 mL. Volume: 0.5 mL. Single dose syringe. For Cook Children's Med Ctr. By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-210-72 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 100 syringes | Class II | Terminated |
| D-0957-2018 | 06-12-2018 | Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS 55 mL) Volume: 55mL. Single dose syringe. Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-76 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 110 syringes | Class II | Terminated |
| D-0946-2018 | 06-12-2018 | fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF, USP 187.5 mg, 0.9% Sodium Chloride, USP QS 150 mL. Volume: 150 mL. Single dose cassette For: Methodist Dallas Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-278-86 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 100 cassettes | Class II | Terminated |
| D-0941-2018 | 06-12-2018 | Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 mL) Volume: 262 mL. Single dose bag. Avella Specialty Pharmacy, 24416N 19th Avenue, Phoenix, AZ 85085. NDC 42852-617-25 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 1,352 bags | Class II | Terminated |
| D-0960-2018 | 06-12-2018 | NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP) 250 mL (Concentration 16 mcg/mL) Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-25 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 2280 bags | Class II | Terminated |
| D-0958-2018 | 06-12-2018 | NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 mL. Volume: 266 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-834-25 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 520 bags | Class II | Terminated |
| D-0943-2018 | 06-12-2018 | ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL). Volume: 10 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-891-61 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 500 syringes | Class II | Terminated |
| D-0933-2018 | 06-12-2018 | fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syringe. For: Hunt Regional Medical Center, By: Advanced Pharma, 9265 Kirby Dr,., Houston, TX 77054. NDC 15082-210-70 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 120 syringes | Class II | Terminated |
| D-0942-2018 | 06-12-2018 | 0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette. For: Parkland Memorial Hospital. By: Advanced Pharma, 9225 Kirby Dr. Houston, TX 77054. Parkland Memorial Hospital NDC 15082-002-87 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 20 bags | Class II | Terminated |
| D-0955-2018 | 06-12-2018 | Midazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 mL) Volume: 30 mL. Single dose syringe. For: Methodist Willowbrook Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-63 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / | Class II | Terminated |
| D-0953-2018 | 06-12-2018 | MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 mL). Volume 255 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-25 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 130 bags | Class II | Terminated |
| D-0962-2018 | 06-12-2018 | PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-894-25 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 120 bags | Class II | Terminated |
| D-0959-2018 | 06-12-2018 | NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-61 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 850 syringes | Class II | Terminated |
| D-0948-2018 | 06-12-2018 | HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 mL) Volume: 251 mL. Single dose bag. For: Adventist Medical Center Hanford. By: Avella of Huston, 9265 Kirby Dr., Houston TX, 77054. NDC 42852-747-25 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 40 bags | Class II | Terminated |
| D-0963-2018 | 06-12-2018 | ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 10500 syringes | Class II | Terminated |
| D-0950-2018 | 06-12-2018 | HYDROmorphone 0.2mg/mL. (Hydromorphone HCL (USP) 20 mg, 0.9% Sodium Chloride (USP) QS 100 mL) Volume: 100mL. Single dose bag. Advanced Pharma, 9265 Kirby Dr., Houston,077054 TX. NDC 15082-221-10 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 660 bags | Class II | Terminated |
| D-0938-2018 | 06-12-2018 | MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 100 mL). Volume 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-10 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 1500 bags | Class II | Terminated |
| D-0934-2018 | 06-12-2018 | HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 mL) Volume: 255 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix AZ 85085. NDC 42852-729-25 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 240 bags | Class II | Terminated |
| D-0949-2018 | 06-12-2018 | HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (USP) QS 30 mL) Volume: 30mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-63 | Lack of Assurance of Sterility: Potential leakage of bags. | Avella of Deer Valley, Inc. Store 38 / 480 syringes | Class II | Terminated |
| D-0887-2018 | 06-12-2018 | Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-122-90 Package NDCs: 55111-121-30; 55111-121-60; 55111-121-90; 55111-121-05; 55111-121-10; 55111-122-30; 55111-122-60; 55111-122-90; 55111-122-05; 55111-122-10; 55111-123-30; 55111-123-60; 55111-123-90; 55111-123-05; 55111-123-10 | Failed Impurities/Degradation Specifications | Dr. Reddy's Laboratories, Inc. / 44,894 bottles | Class III | Terminated |
| D-0886-2018 | 06-12-2018 | Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90 Package NDCs: 55111-121-30; 55111-121-60; 55111-121-90; 55111-121-05; 55111-121-10; 55111-122-30; 55111-122-60; 55111-122-90; 55111-122-05; 55111-122-10; 55111-123-30; 55111-123-60; 55111-123-90; 55111-123-05; 55111-123-10 | Failed Impurities/Degradation Specifications | Dr. Reddy's Laboratories, Inc. / 55,126 bottles | Class III | Terminated |
| D-0888-2018 | 06-12-2018 | Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA Package NDCs: 55111-121-30; 55111-121-60; 55111-121-90; 55111-121-05; 55111-121-10; 55111-122-30; 55111-122-60; 55111-122-90; 55111-122-05; 55111-122-10; 55111-123-30; 55111-123-60; 55111-123-90; 55111-123-05; 55111-123-10 | Failed Impurities/Degradation Specifications | Dr. Reddy's Laboratories, Inc. / 130,081 bottles | Class III | Terminated |
| D-0874-2018 | 06-11-2018 | Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea, CA 92821, NDC 42721-112-08. | CGMP Deviations: Products not manufactured under current good manufacturing practices. | BioDiagnostic International / 1000 boxes | Class II | Terminated |
| D-0893-2018 | 06-08-2018 | TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01 | Labeling: Incorrect or Missing Lot and/or Exp Date. | Qualgen, LLC / | Class III | Terminated |
| D-0892-2018 | 06-08-2018 | ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01 | Labeling: Incorrect or Missing Lot and/or Exp Date. | Qualgen, LLC / 2,940 pellets | Class III | Terminated |
| D-0891-2018 | 06-08-2018 | Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02. Package NDCs: 50742-401-02; 50742-402-05 | Superpotent Drug: High out of specification assay value results for potency. | Ingenus Pharmaceuticals Llc / 14089 vials | Class II | Terminated |
| D-0890-2018 | 06-08-2018 | Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-402-05. Package NDCs: 50742-401-02; 50742-402-05 | Superpotent Drug: High out of specification assay value results for potency. | Ingenus Pharmaceuticals Llc / 34964 vials | Class II | Terminated |
| D-0877-2018 | 06-07-2018 | Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01 | Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification. | Mylan Pharmaceuticals Inc. / 1,620 bottles | Class III | Terminated |
| D-1040-2018 | 06-06-2018 | Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box, NDC 45567-0040-2 , Rx only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821. Package NDCs: 45567-0040-1; 45567-0040-2 | Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility. | Pharmalucence, Inc. / 95 kits | Class II | Terminated |
| D-0854-2018 | 06-05-2018 | HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ | Superpotent and Subpotent | PharMEDium Services, LLC / 2,800 syringes | Class II | Terminated |
| D-0906-2018 | 06-04-2018 | Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and 10 count box (NDC 0409-1782-69), Rx Only, Hospira Inc., Lake Forest, IL Package NDCs: 0409-1782-03; 0409-1782-69 | Presence of Particulate Matter; Potential for particulate matter on the syringe plunger. | HOSPIRA INC, LAKE FOREST / 164,860 syringes | Class I | Terminated |
| D-0883-2018 | 05-31-2018 | 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23 | Lack of assurance of sterility: Bags have potential to leak. | ICU Medical Inc / 525984 bags | Class II | Terminated |
| D-0881-2018 | 05-31-2018 | 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37 | Lack of assurance of sterility: Bags have potential to leak. | ICU Medical Inc / 88960 bags | Class II | Terminated |
| D-0884-2018 | 05-31-2018 | 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37 | Lack of assurance of sterility: Bags have potential to leak. | ICU Medical Inc / 1247200 bags | Class II | Terminated |
| D-0885-2018 | 05-31-2018 | 5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02 | Lack of assurance of sterility: Bags have potential to leak. | ICU Medical Inc / 267288 bags | Class II | Terminated |
| D-0882-2018 | 05-31-2018 | 0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02 | Lack of assurance of sterility: Bags have potential to leak. | ICU Medical Inc / 941496 bags | Class II | Terminated |
| D-0841-2018 | 05-31-2018 | Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326, NDC 60505-0829-1 Package NDCs: 60505-0829-1 | Presence of foreign substance: glass particles | Apotex Inc. / Unknown | Class II | Terminated |
| D-0878-2018 | 05-30-2018 | Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900 Package NDCs: 55111-124-30; 55111-124-60; 55111-124-90; 55111-124-05; 3551111249 | Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle. | Dr. Reddy's Laboratories, Inc. / 6,397 bottles | Class II | Terminated |
| D-0865-2018 | 05-29-2018 | Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05 Package NDCs: 0121-0810-02; 0121-0810-16; 0121-4810-05; 0121-4810-40; 0121-4810-00; 0121-4810-50 | Resuspension problems: Out of specification for appearance and resuspendability. | Pharmaceutical Associates Inc / 275400 cups | Class III | Terminated |
| D-0861-2018 | 05-25-2018 | Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic acid) Shave Cream Acne Shield, one tube Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5% tube, and one Power Shaver per box, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos CA 90703 USA, UPC 7 80707 73114 7. | CGMP Deviations: products may be contaminated with bacteria. | Shadow Holdings DBA Bocchi Labs / 4,932 boxes | Class II | Terminated |
| D-0860-2018 | 05-25-2018 | Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL) tube, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos, CA 90703 USA, UPC 7 80707 73111 6. | CGMP Deviations: products may be contaminated with bacteria. | Shadow Holdings DBA Bocchi Labs / 8,208 tubes | Class II | Terminated |
| D-0858-2018 | 05-25-2018 | X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 00503 3, Distributed by Herb-X Solutions, Inc., 3838 West Burbank Blvd., Burbank CA 91505. | CGMP Deviations: products may be contaminated with bacteria. | Shadow Holdings DBA Bocchi Labs / 12,252 bottles | Class II | Terminated |
| D-0859-2018 | 05-25-2018 | Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5%, 3.3 FL OZ (98 mL) tube, Distributed by: United Exchange Corp., 17211 Valley View Blvd., Cerritos, CA 90703 USA, UPC 7 80707 73112 3. | CGMP Deviations: products may be contaminated with bacteria. | Shadow Holdings DBA Bocchi Labs / 15,216 tubes | Class II | Terminated |
| D-0876-2018 | 05-25-2018 | Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90 Package NDCs: 59746-360-30; 59746-360-90; 59746-360-05; 59746-360-03; 59746-361-30; 59746-361-90; 59746-361-05; 59746-361-03; 59746-362-30; 59746-362-90; 59746-362-05; 59746-362-03; 59746-363-30; 59746-363-90; 59746-363-67; 59746-363-32 | Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone). | Jubilant Cadista Pharmaceuticals, Inc. / 2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A) | Class III | Terminated |
| D-0836-2018 | 05-24-2018 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102 Package NDCs: 43386-358-05; 43386-358-01; 43386-358-10; 43386-358-03; 43386-357-01; 43386-357-05; 43386-357-10; 43386-357-03; 43386-356-01; 43386-356-05; 43386-356-10; 43386-356-03; 3433863561 | Labeling: Missing Label | LUPIN SOMERSET / 1,672 (1000-count) bottles | Class III | Terminated |
| D-0875-2018 | 05-24-2018 | Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample - Not for Sale Distributed by: Allergan USA INC Irvine, CA 92612 NDC 0023-5862-28 (Blister Card) NDC 0023-5862-29 (Blister Carton) NDC 0023-5862-31 (Outer carton) UPC 300235862290 Package NDCs: 0023-5862-28; 0023-5862-30; 0023-5862-29; 0023-5862-31; 3002358622 | Contraceptive Tablets Out of Sequence. | Allergan, PLC. / 168,768 blister cards (4,725,504 softgel capsules) | Class I | Terminated |
| D-0855-2018 | 05-22-2018 | READYFLUSH PROTECT with Dimethicone (3.2%), Flushable Personal Cleaning Cloths, 24-count flexible pack. Manufactured by Medline Industries, Inc. Mundelein, IL 60060 USA. NDC 53329-066-58. | Microbial Contamination of a Non-Sterile Product. | Medline Industries Inc (Northpoint Services) / 19,0800 24-count flexible packs | Class II | Terminated |
| D-1067-2018 | 05-17-2018 | Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 60 20-ml syringes | Class II | Terminated |
| D-1063-2018 | 05-17-2018 | Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 300 2-ml syringes | Class II | Terminated |
| D-1061-2018 | 05-17-2018 | Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 60 5-ml vials | Class II | Terminated |
| D-0880-2018 | 05-17-2018 | 7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148 | Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. | Shoreside Enterprises Inc. / Unknown | Class I | Terminated |
| D-1070-2018 | 05-17-2018 | Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 100 50-ml vials | Class II | Terminated |
| D-1064-2018 | 05-17-2018 | Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 20 400-ml ON-Q Pump | Class II | Terminated |
| D-1051-2018 | 05-17-2018 | Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 20 25-ml CADD | Class II | Terminated |
| D-0879-2018 | 05-17-2018 | POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857 | Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. | Shoreside Enterprises Inc. / Unknown | Class I | Terminated |
| D-1057-2018 | 05-17-2018 | Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 100 2-ml syringes | Class II | Terminated |
| D-1073-2018 | 05-17-2018 | Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 40 10-ml vials | Class II | Terminated |
| D-1068-2018 | 05-17-2018 | Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 100 50-ml vials | Class II | Terminated |
| D-1071-2018 | 05-17-2018 | Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 2000 100-ml vials | Class II | Terminated |
| D-1053-2018 | 05-17-2018 | Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 5000 500-ml bags | Class II | Terminated |
| D-1054-2018 | 05-17-2018 | B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 2600 100 ml bags/vials | Class II | Terminated |
| D-1055-2018 | 05-17-2018 | EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 1 1-ml syringe | Class II | Terminated |
| D-1058-2018 | 05-17-2018 | Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 2 1-ml vials | Class II | Terminated |
| D-1056-2018 | 05-17-2018 | Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 2400 100-ml vials | Class II | Terminated |
| D-1059-2018 | 05-17-2018 | Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL syringes. Refridgerate. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 442 1-ml syringes | Class II | Terminated |
| D-0838-2018 | 05-17-2018 | My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, INDIA, UPC 3 68180 85212 4. | Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release. | Lupin Pharmaceuticals Inc. / 43,640 cartons | Class II | Terminated |
| D-1066-2018 | 05-17-2018 | Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 3 750-ml ON-Q Pump | Class II | Terminated |
| D-1069-2018 | 05-17-2018 | Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 250 10-ml syringes | Class II | Terminated |
| D-1072-2018 | 05-17-2018 | MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 250 50-ml vials | Class II | Terminated |
| D-1065-2018 | 05-17-2018 | Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 25 550-ml ON-Q Pump | Class II | Terminated |
| D-1062-2018 | 05-17-2018 | Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Lack of sterility assurance. | Guardian Pharmacy Services / 95 1-ml syringes | Class II | Terminated |
