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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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	Subpotency: lower than expected potency result was obtained at the 18 month stability time point.	Validus Pharmaceuticals, Inc. / 696 bottles	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	Subpotency: lower than expected potency result was obtained at the 18 month stability time point.	Validus Pharmaceuticals, Inc. / 7864 bottles	Class III	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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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.	Superpotent Drug: High out of specification assay value results for potency.	Ingenus Pharmaceuticals Llc / 34964 vials	Class II	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.	Superpotent Drug: High out of specification assay value results for potency.	Ingenus Pharmaceuticals Llc / 14089 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