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 10, 2025 and include a total of 17129 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0972-2018 | 07-13-2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-311-09 Package NDCs: 43547-311-03; 43547-311-09; 43547-311-50; 43547-312-03; 43547-312-09; 43547-312-50; 43547-313-03; 43547-313-09; 43547-313-50; 43547-314-03; 43547-314-09; 43547-314-50; 43547-315-03; 43547-315-09; 43547-315-50 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Prinston Pharmaceutical Inc / N/A | Class II | Ongoing |
| D-0968-2018 | 07-13-2018 | Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-367-03 Package NDCs: 43547-367-03; 43547-367-09; 43547-367-50; 43547-367-11; 43547-368-03; 43547-368-09; 43547-368-50; 43547-368-11; 43547-369-03; 43547-369-09; 43547-369-50; 43547-369-11; 43547-370-03; 43547-370-09; 43547-370-50; 43547-370-11 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Prinston Pharmaceutical Inc / N/A | Class II | Ongoing |
| D-0974-2018 | 07-13-2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-313-09 Package NDCs: 43547-311-03; 43547-311-09; 43547-311-50; 43547-312-03; 43547-312-09; 43547-312-50; 43547-313-03; 43547-313-09; 43547-313-50; 43547-314-03; 43547-314-09; 43547-314-50; 43547-315-03; 43547-315-09; 43547-315-50 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Prinston Pharmaceutical Inc / N/A | Class II | Ongoing |
| D-0977-2018 | 07-12-2018 | Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40 Package NDCs: 62756-017-40; 62756-015-40; 62756-016-40 | Presence of Particulate Matter: organic and inorganic compounds detected in vials of product. | Sun Pharmaceutical Industries, Inc. / 5215 units | Class II | Terminated |
| D-1032-2018 | 07-11-2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-002-10. | Failed Stability Specifications: lot out of specification for elevated water vapor. | Renaissance Lakewood, LLC / 3664 bags | Class III | Terminated |
| D-1031-2018 | 07-11-2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06. | Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor. | Renaissance Lakewood, LLC / 3000 bags | Class III | Terminated |
| D-1033-2018 | 07-11-2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06. | Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay. | Renaissance Lakewood, LLC / 12088 bags | Class III | Terminated |
| D-1041-2018 | 07-10-2018 | Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instructions for use per carton, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807; Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215; NDC 68682-650-20. Package NDCs: 68682-652-20; 68682-655-20; 68682-650-20 | Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton. | Valeant Pharmaceuticals North America LLC / 306 cartons | Class III | Terminated |
| D-0978-2018 | 07-09-2018 | Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01 | Subpotent Drug | Mylan Pharmaceuticals Inc. / 28,436 bottles | Class III | Terminated |
| D-0920-2018 | 07-05-2018 | alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf 45, 170 g (6 oz) tubes packaged in a) 4 tubes per case; b) 8 pack shipper display; Manufactured By: The Hain Celestial Group, Inc., Lake Success, NY 11042, UPC 7 24742 01102 4. | Incorrect Product Formulation: wrong sunscreen product in the package. | The Hain Celestial Group, Inc. - Worldwide HQ / 47,128 tubes | Class II | Terminated |
| D-0909-2018 | 07-05-2018 | Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60. Package NDCs: 0591-2990-60 | Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants. | Teva Pharmaceuticals USA / 27,803 bottles | Class II | Terminated |
| D-0925-2018 | 07-05-2018 | Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00 Package NDCs: 0024-5924-10; 0024-5925-01; 0024-5925-05; 0024-5925-00; 0024-5926-05 | Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature. | Sanofi-Aventis U.S. LLC / 3214 prefilled pens | Class II | Ongoing |
| D-0924-2018 | 07-03-2018 | Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat. India, NDC 62756-142-02 Package NDCs: 62756-142-01; 62756-142-02; 62756-143-01 | Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet. | Sun Pharmaceutical Industries, Inc. / 2508 bottles | Class II | Terminated |
| D-0917-2018 | 07-03-2018 | 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: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices. | Medgyn Products, Inc. / 2750 boxes | Class II | Terminated |
| D-0919-2018 | 07-03-2018 | Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West Pine St., Blacksburg, SC 29702 800-622-0007 | CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL. | Medi-Fare Drug and Home Health Center / 1116 syringes | Class II | Terminated |
| D-1030-2018 | 07-02-2018 | Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Manufactured for: Auromedics Pharma LLC 6 Wheeling Road Dayton NJ 08810, Made in India. NDC 55150-120-30 Package NDCs: 55150-119-30; 55150-120-30; 55150-121-50 | Presence of Particulate Matter: identified as glass and silicone material | AuroMedics Pharma LLC / 73620 single-dose vials | Class I | Terminated |
| D-0918-2018 | 06-29-2018 | Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205 877-550-5059 | Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding. | SCA Pharmaceuticals / 3984 syringes | Class II | Terminated |
| D-0910-2018 | 06-29-2018 | Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-02. | Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL. | Fagron Compounding Services LLC dba Fagron Sterile Services / 840 prefilled syringes | Class I | Terminated |
| D-0911-2018 | 06-29-2018 | Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-01. | Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL. | Fagron Compounding Services LLC dba Fagron Sterile Services / 390 prefilled syringes | Class I | Terminated |
| D-0927-2018 | 06-28-2018 | Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11 Package NDCs: 43386-450-11 | Subpotent Drug and Failed Content Uniformity. | LUPIN SOMERSET / 3456 cartons | Class II | Terminated |
| D-1023-2018 | 06-28-2018 | Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01. | Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination. | PFIZER / 234,680 vials | Class II | Terminated |
| D-0991-2018 | 06-27-2018 | Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90 | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability. | Aidarex Pharmaceuticals LLC / 61, 90-count bottles | Class III | Terminated |
| D-0992-2018 | 06-27-2018 | Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30 | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability. | Aidarex Pharmaceuticals LLC / 25, 30-count bottles | Class III | Terminated |
| D-0990-2018 | 06-27-2018 | Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90 | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability. | Aidarex Pharmaceuticals LLC / 11, 90-count bottles | Class III | Terminated |
| D-1122-2018 | 06-26-2018 | Blissful Remedies Red Maeng Da, 100% Mitragyna Speciosa capsule, 50-count packaged White Foil Pouche, Dist. by World Organix LLC, Las Vegas, Nevada UPC#7 22589 32355 3 | Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads. | World Organix, LLC / 789 50-count pouches, total of 39,450 capsules | Class I | Terminated |
| D-0980-2018 | 06-26-2018 | Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed by: MAJOR Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152; NDC 0904-5502-61. | Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product. | MAJOR PHARMACEUTICALS / 5,933 cartons | Class III | Terminated |
| D-1125-2018 | 06-26-2018 | Blissful Remedies Gold Series Ultra Enhanced Indo, 50 capsule, packaged in While Foil Pouch, Dist. by World Organix LLC, Las Vegas Nevada UPC# 6 02401 88900 2 | Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads. | World Organix, LLC / 545 50-count pouches, 27,250 capsules | Class I | Terminated |
| D-1126-2018 | 06-26-2018 | Blissful Remedies Kratom+CBD CBD infused Maeng Da, capsules 50-count packaged in While Foil Pouch. Dist. by World Organix LLC, Las Vegas Nevada UPC# 7 11583 27057 4 | Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads. | World Organix, LLC / 553 50-count pouch, 27,650 capsules | Class I | Terminated |
| D-1124-2018 | 06-26-2018 | Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, 12mL bottle. Distributed by World Organix LLC Las Vegas Nevada. UPC#7 14983 56525 7 | Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads. | World Organix, LLC / 681 12 mL-bottle | Class I | Terminated |
| D-1123-2018 | 06-26-2018 | Blissful Remedies, 4 Hour Chill, Slow Motion Blend, Herbal Shot. 1.93 Fluid Oz (57ml) UPC#6 02401 88900 3. | Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads. | World Organix, LLC / 164 2oz bottles | Class I | Terminated |
| D-0979-2018 | 06-26-2018 | Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed by: MAJOR Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152; NDC 0904-5609-61. | Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product. | MAJOR PHARMACEUTICALS / 3,397 cartons | Class III | Terminated |
| D-0915-2018 | 06-25-2018 | Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit Dose] | Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant | AMERICAN HEALTH PACKAGING / 1285 cartons (cartons of 100 individual unit doses) | Class III | Terminated |
| D-0921-2018 | 06-25-2018 | Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500 | Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile. | La Vita Compounding Pharmacy, LLC / 19,040 mL total dispensed in 10 mL and 30 mL vials | Class II | Terminated |
| D-0923-2018 | 06-25-2018 | Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, Rx only, la VITA Compounding Pharmacy, 858.453.2500 | Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile. | La Vita Compounding Pharmacy, LLC / 191 vials | Class II | Terminated |
| D-0922-2018 | 06-25-2018 | Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500 | Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile. | La Vita Compounding Pharmacy, LLC / 17,610 mL total dispensed in 10 mL and 30 mL vials | Class II | Terminated |
| D-0908-2018 | 06-22-2018 | eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone. 177.4 ml / 6 fl oz carton containing a tube. Manufactured For: EB5 Corporation Portland, OR 97210 Carton Bar Code: 7 41099 00009 9 | Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity | Eb5 Corporation / 4,632 tubes | Class II | Terminated |
| D-0916-2018 | 06-22-2018 | Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30. | CGMP Deviations | Akorn, Inc. / 89,507 vials | Class II | Terminated |
| D-1011-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, White Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1010-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1016-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Yellow Vietnam, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1014-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, White Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1001-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Green Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1013-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, White MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-0997-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Green Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1005-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Red Bali, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia Ethnobotanical Red Borneo, 1oz, 250g, kg Gaia Ethnobotanical Red Dragon, 1oz, 250g, 1kg Gaia Ethnobotanical Red Horn, 1oz, 250g, 1kg Gaia Ethnobotanical Red Kapuas Hulu 1oz, 250g, 1kg Gaia Ethnobotanical Red MD, 1oz, 250g, 1kg Gaia Ethnobotanical Red Thai, 1oz, 250g,. 1kg Gaia Ethnobotanical Super Green Malay 1oz, 250g, 1kg Gaia Ethnobotanical White Borneo 1oz, 250g, 1kg Gaia Ethnobotanical White Horn, 1 oz, 250g, 1kg Gaia Ethnobotanical White MD, 1 oz, 250 g, 1 kg Gaia Ethnobotanical White Thai, 1oz, 250 g, 1 kg Gaia Ethnobotanical Yellow Thai, 1oz, 250 g, 1kg Gaia Ethnobotanical Yellow Vietnam 1oz, 250g, 1kg | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1007-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Red Dragon, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1000-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Green MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / | Class I | Terminated |
| D-1012-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, White Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1004-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Purple 8-1, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1003-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Plantation White MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / | Class I | Terminated |
| D-1015-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Yellow Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-0996-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Green Dragon, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-0994-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Elephant, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1006-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Red Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1008-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Red Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-0995-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Ganesh, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-0889-2018 | 06-20-2018 | fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72. | Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label. | Advanced Pharma Inc. / 100 syringes | Class II | Terminated |
| D-1002-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Plantation Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-0998-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Green Kapuas Hulu, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-1009-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Red Kapuas Hulu , 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-0993-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Bali Gold, 1oz, 250g 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-0999-2018 | 06-20-2018 | Gaia Kratom (mitragyna speciosa) powder, Green Malay, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Gaia Ethnobotanical LLC / unknown | Class I | Terminated |
| D-0912-2018 | 06-19-2018 | Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons. | Failed Impurities/Degradation Specifications | Wockhardt Limited / 31,710 tablets | Class III | Terminated |
| D-0913-2018 | 06-19-2018 | Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons. | Failed Impurities/Degradation Specifications | Wockhardt Limited / 17,628 tablets | Class III | Terminated |
| D-1170-2018 | 06-15-2018 | Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59 Package NDCs: 63304-239-30; 63304-239-01; 63304-240-01; 63304-241-59 | Subpotency: lower than expected potency result was obtained at the 18 month stability time point. | Validus Pharmaceuticals, Inc. / 7864 bottles | Class III | Terminated |
| D-1171-2018 | 06-15-2018 | Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15 Package NDCs: 30698-143-23; 30698-143-01; 30698-144-01; 30698-911-15 | Subpotency: lower than expected potency result was obtained at the 18 month stability time point. | Validus Pharmaceuticals, Inc. / 696 bottles | Class III | Terminated |
| D-0901-2018 | 06-14-2018 | Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 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-0905-2018 | 06-14-2018 | Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 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 / 196 bags | Class II | Terminated |
| D-0894-2018 | 06-14-2018 | Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, 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 / 440 syringes | Class II | Terminated |
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
