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 November 24, 2022 and include a total of 14663 recall reports.

Recall Number Initiation Date Product Description Recall Reason Recall Firm / Quantity Recall Classification Status
D-1465-202208-10-2022Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevention, 5% Hydrogen Peroxide, Net Wt. 2.1 OZ. (59 g) UPC 0 35000 99658 9. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.cGMP deviation: Product held outside of appropriate temperature storage conditions.Family Dollar Stores, Llc. / 1120 packagesClass IIOngoing
D-1344-202208-10-2022PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.Nephron Sterile Compounding Center LLC / 13,500 vialsClass IIOngoing
D-1470-202208-10-2022Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 473 mL UPC 0 35000 67111 0. Dist. by: Colgate-Palmolive Co. New York, NY 10022 U.S.A.cGMP deviation: Product held outside of appropriate temperature storage conditions.Family Dollar Stores, Llc. / 840 packagesClass IIOngoing
D-1468-202208-10-2022Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT PASTE, Net Wt. 4.2 OZ. UPC 0 35000 97872 1. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.cGMP deviation: Product held outside of appropriate temperature storage conditions.Family Dollar Stores, Llc. / 840 packagesClass IIOngoing
D-1354-202208-10-2022Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01
Package NDCs: 0487-6232-01
cGMP Deviations: deviations leading to potential cross-contamination.Nephron Sc Inc / 5040 vialsClass IIOngoing
D-1469-202208-10-2022Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT PASTE. Net Wt. 4.2 OZ. (119 g) UPC 0 35000 45836 0. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.cGMP deviation: Product held outside of appropriate temperature storage conditions.Family Dollar Stores, Llc. / 1400 packagesClass IIOngoing
D-1467-202208-10-2022Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH, Net Wt. 3.2 OZ. (90 g) UPC 0 35000 97159 3. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.cGMP deviation: Product held outside of appropriate temperature storage conditions.Family Dollar Stores, Llc. / 1680 packagesClass IIOngoing
D-1466-202208-10-2022Colgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Peroxide, High Impact White, Net Wt. 3.0 OZ. (85 g) UPC 0 35000 97008 4. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.cGMP deviation: Product held outside of appropriate temperature storage conditions.Family Dollar Stores, Llc. / 840 packagesClass IIOngoing
D-1345-202208-10-2022Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-910-04CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.Nephron Sterile Compounding Center LLC / 294 bagsClass IIOngoing
D-1347-202208-10-2022PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.Nephron Sterile Compounding Center LLC / 33,870 vialsClass IIOngoing
D-1471-202208-08-2022Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24
Package NDCs: 17478-189-24
Identification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide.Akorn, Inc / 5,226 Cartons (60 vials/carton)Class IIIOngoing
D-1464-202208-08-2022Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%)128 Fl. Oz. (1 Gal.) 3.78 liters bottles, Southern Products & Services, Inc. 2515 Jake Drive Ste B, Cumming, GA 30028CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.Midlab Incorporated / Class IIOngoing
D-1463-202208-08-2022Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a) 1 U.S. Gallon (3.78 Liters) drums UPC 7 61841 02502 6 and b) 55 U.S. Gallon drums (208 Liters) UPC 0 07 61841 02504 0, Midlab 140 Private Brand Way, Athens, TN 37303CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.Midlab Incorporated / 892 gallons and one 55-gallon drumClass IIOngoing
D-1353-202208-04-2022Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJFailed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.Akron Pharma, Inc. / 30,325 bottlesClass IIIOngoing
D-1348-202208-04-2022Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC 36000-306-60
Package NDCs: 36000-306-60
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.Baxter Healthcare Corporation / 85,680 bagsClass IIOngoing
D-1472-202208-04-2022Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4.Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.LNK International, Inc. / 257,064 cartonsClass IIIOngoing
D-1352-202208-04-2022Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJFailed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.Akron Pharma, Inc. / 301,382 bottlesClass IIIOngoing
D-1328-202208-02-2022Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
Package NDCs: 69097-341-35
Lack of Assurance of Sterility: Complaints received of defective container closure.CIPLA / 7,992 bottlesClass IIOngoing
D-1335-202208-02-2022Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only, Manufactured for Heron Therapeutics, Inc., San Diego, CA, NDC 47426-301-02
Package NDCs: 47426-301-02; 47426-302-02; 47426-303-01; 47426-304-01
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kitHERON THERAPEUTICS, INC. / 1790 kitsClass IIIOngoing
D-1361-202208-01-2022PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24
Package NDCs: 50383-042-48; 50383-042-24
Defective Container: Product has incomplete induction seals.Akorn, Inc / 14,712 bottlesClass IIOngoing
07-29-2022Banana Boat Hair & Scalp Defense, Clear Sunscreen Spray SPF 30, packaged in aluminum spray can, Net Wt 6 oz., Distributed by: Edgewell Personal Care Brands, LLC, Shelton, CT 06484, UPC 0 7965604041 8Chemical contamination: presence of BenzeneEdgewell Personal Care Brands, LLC / 139,680 aluminum spray cansNot Yet ClassifiedOngoing
D-1343-202207-28-2022Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06
Package NDCs: 68180-658-06; 68180-658-01; 68180-659-06; 68180-659-01; 68180-659-07
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.Lupin Pharmaceuticals Inc. / 7,872/30 count bottlesClass IIOngoing
D-1349-202207-27-2022Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56Subpotent DrugAmerisource Health Services LLC / 4,160 vialsClass IIIOngoing
D-1362-202207-27-2022Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10
Package NDCs: 65162-755-10; 65162-755-50; 65162-757-10; 65162-757-50
Failed dissolution specifications.Amneal Pharmaceuticals of New York, LLC / 4,309 bottlesClass IIOngoing
D-1514-202207-27-2022Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syringe, Item# 803, barcode 6919408031; b) 5 mL prefilled syringe, Item# 933, barcode 6919409331, Rx only, Pine Pharmaceuticals, 355 Riverwalk Parkway, Tonawanda, NY 14150.Lack of Assurance of SterilityPine Pharmaceuticals, LLC / a) 920 syringes; b) 3263 syringesClass IITerminated
D-1332-202207-25-2022fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.Lack of Assurance of SterilitySterRx, LLC / 360 bagsClass IIOngoing
D-1331-202207-25-2022FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.Lack of Assurance of SterilitySterRx, LLC / 720 bagsClass IIOngoing
D-1334-202207-22-2022Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Package NDCs: 68001-313-56
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.Teva Pharmaceuticals USA Inc / 4162 cartonsClass IIIOngoing
D-1333-202207-22-2022SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC, (800) 519-0204 Miami 33172 FL, USA; UPC 0 705632 523285Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.Distributor RFR, LLC. / 2000 cartonsClass IOngoing
D-1302-202207-21-2022Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA; NDC 52544-691-30.
Package NDCs: 52544-691-10; 52544-691-19; 52544-691-30; 52544-692-10; 52544-692-19; 52544-692-30; 52544-693-10; 52544-693-19; 52544-693-30; 52544-694-10; 52544-694-19; 52544-694-30; 52544-695-10; 52544-695-19; 52544-695-30
Failed Dissolution Specifications: below specification limits for dissolution.Teva Pharmaceuticals USA Inc / 8022 bottlesClass IIOngoing
D-1350-202207-21-2022SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.Ultra Supplement LLC / 750 cartonsClass IOngoing
D-1303-202207-21-2022Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054 USA; NDC 58544-692-30.Failed Dissolution Specifications: below specification limits for dissolution.Teva Pharmaceuticals USA Inc / 5677 bottlesClass IIOngoing
D-1329-202207-20-2022Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4
Package NDCs: 42291-366-01; 42291-366-10; 42291-367-01; 42291-367-10; 42291-368-60; 42291-368-50; 42291-369-60; 42291-369-50
Labeling: Label Error on Declared StrengthAVKARE Inc. / 8328 bottlesClass IIIOngoing
D-1330-202207-19-2022Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-785-06.
Package NDCs: 64380-784-01; 64380-784-07; 64380-784-08; 64380-784-06; 64380-785-06; 64380-785-07; 64380-785-08; 64380-785-01; 64380-949-06; 64380-949-01
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone TabletsStrides Pharma Inc. / 1032 bottlesClass IIOngoing
D-1475-202207-19-2022Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ. (1 PT) 355 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965765.Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcoholTsm Brands LLC / 350,000 bottlesClass IIOngoing
D-1474-202207-19-2022Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcoholTsm Brands LLC / 2,700,000 bottlesClass IIOngoing
D-1293-202207-18-2022Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90
Package NDCs: 59746-447-30; 59746-447-90; 59746-447-05; 59746-448-30; 59746-448-90; 59746-448-05; 59746-449-30; 59746-449-90; 59746-449-05
Failed dissolution specifications.Jubilant Cadista Pharmaceuticals, Inc. / 9,600 bottlesClass IIOngoing
D-1294-202207-18-2022Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-447-90
Package NDCs: 59746-447-30; 59746-447-90; 59746-447-05; 59746-448-30; 59746-448-90; 59746-448-05; 59746-449-30; 59746-449-90; 59746-449-05
Failed Dissolution SpecificationsJubilant Cadista Pharmaceuticals, Inc. / 28,560 bottlesClass IIOngoing
D-1355-202207-15-2022Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.Aire-Master of America Inc / 18 oz bottle: 11,435 bottles; 1000 mL pouch: 4,116 pouches, c) 2 drumsClass IIOngoing
D-1359-202207-15-2022Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.Aire-Master of America Inc / 5,064 bottlesClass IIOngoing
D-1512-202207-15-2022Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Cherry Flavor, 10 FL OZ (296 mL), a) Best Choice UPC 0 70038 58790 3 Proudly Distributed By: Valu Merchandises, Co. 5000 Kansas Ave. Kansas City, KS 66106; b) Careone UPC 3 41520 00055 3 Distributed By: Foodhold U.S.A., LLC, Landover, MD 20785, Careone UPC 3 41520 00055 3 Distributed By: Adusa Distribution, LLC Salisbury, NC 28147; c) CVS Health UPC 0 50428 29733 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, CVS Health UPC 0 50428 28515 2 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; d) Equaline NDC 41163-769-38 UPC 0 41163 50068 6 Distributed by Supervalu Inc. Eden Prairie, MN 55344 USA, Equaline NDC: 41163-769-38 UPC 0 41163 50068 6 Distributed By UNFI Providence, RI 02908; Equate NDC 49035-593-38 UPC 6 81131 28716 6 Distributed By: Walmart Inc., Bentonville, AR 72716; Family Wellness NDC 56319-164-38 UPC 0 32251 57788 8; e) GoodSense NDC 50804-164-38 UPC 8 46036 00739 8 Distributed By: Geiss, Destin & Dunn, Inc. Peachtree City, GA 30269, GoodSense NDC 508-164-38 UPC 8 46036 00739 8 Distributed by: Geiss, Destin & Dunn, Inc. A Perrigo Company, Peachtree City, GA 30269; f) HEB UPC 0 41220 51087 0 Made with Pride & Care For H-E-B San Antonio, TX 78204; g) Health Mart NDC 62011-0381-1 UPC 0 52569 14216 5 Distributed by McKesson One Post Street, San Francisco, CA 94104, Health Mart NDC 62011-0381-1 NDC 0 52569 14216 5 Distributed by McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141; h) Leader Sugar-Free NDC 70000-0575-1 UPC 0 96295 14106 1 Distributed By Cardinal Health Dublin, Ohio 43017, Leader Sugar-Free NDC 70000-0576-1 UPC 0 96295 14105 4 Distributed By Cardinal Health Dublin, Ohio 43017; i) Meijer Sugar Free Low Sodium NDC 41250-769-38 UPC 7 13733 45944 0 Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544; j) Premier Value UPC 8 40986 03529 6 Distributed by: Pharmacy Value Alliance LLC 407 East Lancaster Avenue, Wayne, PA 19087; k) P NDC 56062-264-38 UPC 0 41415 50573 5 Distributed By Publix Super Markets, Inc. 3300 Publix Corporation Parkway, Lakeland, FL 33811; l) Quality Choice UPC 6 35515 90111 7 Distributed by C.D.M.A., Inc. 43157 W 9 Mile Rd Novi, MI 48375; Rexall UPC 0 72785 13416 4 Distributed By Dolgencorp, LLC 100 Mission Ridge Goodlettsville, TN 37072 USA, Rexall UPC 0 72785 13416 4 Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072; m) Rite Aid NDC 11822-4303-2 UPC 0 11822 43303 7 Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011; Signature Care NDC 21130-165-38 UPC 3 21130 78971 0 Distributed By Better Living Brands LLC P.O. Box 99, Pleasanton, CA 94566; n) Sunmark NDC 70677-0053-1 UPC 0 10939 91044 8 Distributed By McKesson One Post Street, San Francisco, CA 94104; o) Swan Very Low Sodium NDC 0869-0164-38 UPC 3 08690 69338 1 Distributed by: Vi-Jon, Inc. One Swan Drive Smyrna, TN 37167; p) TopCare Health NDC 36800-164-38 UPC 0 36800 45530 6 Distributed By Topco Associates LLC Elk Grove Village, IL 60007; q) Walgreens NDC 0363-8164-38 UPC 3 11917 20158 0 Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 (red label), Walgreens NDC 0363-8164-38 UPC 3 11917 20158 0 Distributed By: Walgreen Co. 200 Wilmot RD., Deerfield, IL 60015
Package NDCs: 41163-769-38; 49035-593-38; 50804-164-38; 62011-0381-1; 70000-0575-1; 70000-0576-1; 41250-769-38; 56062-264-38; 11822-4303-2; 21130-165-38; 70677-0053-1; 0869-0164-38; 36800-164-38; 0363-8164-38; 56319-164-38
CGMP DeviationsVi-Jon, LLC / 10,070,526Class IIOngoing
D-1501-202207-15-2022equate Magnesium Citrate, SALINE LAXATIVE, (1.745g/fl oz) 10 FL OZ (296mL), Grape Flavor, Distributed By: Walmart, Inc. Bentonville, AR 72716; NDC 49035-592-38 UPC 6 81131 28715 9
Package NDCs: 49035-592-38
Microbial contamination of non-sterile products.Vi-Jon, LLC / 18,324 bottlesClass IOngoing
D-1511-202207-15-2022Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), a) CVS Health UPC 0 50428 33517 8 or UPC 0 50428 30594 2 Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895; b) Best Choice UPC 0 70038 20049 9 Proudly Distributed By: Valu Merchandisers, Co. 5000 Kansas Ave Kansas City, KS 66106; c) Care One UPC 3 41520 31322 6 Distributed By: Foodhold U.S.A., LLC, Landover, MD 20785 or Distributed By: Adusa Distribution, LLC Salisbury, NC 28147; d) Cariba UPC 6 46702 05701 2 Distributed by: Cariba International P.O. Box 1208 Safety Harbor, Florida 34595; e) Cruz Blanca UPC 3 0869-7403-08 2 or 3 08697 40308 2 Fabricado por Vi-Jon Inc. Smyrna, TN 37167 U.S.A. Dist.; f) Discount Drug Mart UPC 0 93351 02820 5 Distributed By: Discount Drug Mart 211 Commerce Drive, Medina, Ohio 44256; g) Equaline NDC 41163-709-38 UPC 0 41163 50067 9 Distributed by SUPERVALU INC. Eden Prairie, MN 55344 USA or Distributed By UNFI Providence, RI 02908 USA; h) Equate NDC 49035-506-38 UPC 6 81131 28714 2 Distributed By: Walmart Inc., Bentonville, AR 72716; i) Exchange Select 6 14299 40420 5 Manufactured For Your Military Exchanges By: Vi-Jon Inc. 8515 Page Avenue, St. Louis, MO 63114; j) Family Wellness UPC 0 32251 58082 6 Distributed By: Midwood Brands, LLC 500 Volvo Parkway Chesapeake, VA 23330; k) Good Sense NDC 50804-166-38 UPC 8 46036 00737 4 Distributed By: Geiss, Destin & Dunn, Inc. Peachtree City, GA 30269 or Distributed by: Perrigo Direct, Inc. Peachtree City, GA 30269; l) Harris Teeter UPC 0 72036 72612 4 Proudly Distributed By: Harris Teeter, LLC Matthews, NC 28105; m) HEB UPC 0 41220 51086 3 Made With Pride & Care For H-E-B San Antonio, TX 78204; n) Health Mart NDC 62011-0380-1 UPC 0 52569 14215 8 Distributed by McKesson One Post Street, San Francisco, CA 94104; o) Kroger NDC 30142-899-38 UPC 0 41260 00182 6 Distributed By The Kroger CO Cincinnati, Ohio 45202; p) Leader Sugar-Free NDC 70000-0424-1 UPC 0 96295 13554 1 Distributed By Cardinal Health Dublin, OH 43017; q) Major NDC 0904-6787-44 UPC 3 09046 78744 0 Distributed By: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152; r) Meijer NDC 41250-708-38 UPC 7 13733 45945 7 Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544; s) Premier Value UPC 8 40986 03530 2 Distributed by: Pharmacy Value Alliance LLC. 407 East Lancaster Avenue, Wayne, PA 19087; t) Publix NDC 56062-266-38 UPC 0 41415 50673 2 Distributed By Publix Super Markets, Inc. 3300 Publix Corporate Parkway, Lakeland, FL 33811; u) Quality Choice UPC 6 35515 90125 4 Distributed by C.D.M.A., Inc. 43157 W 9 Mile Rd Novi, MI 48375; v) Rexall UPC 0 72785 13418 8 Distributed By Dolgencorp. LLC 100 Mission Ridge Goodlettsville, TN 37072 or Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072; w) Rite Aid NDC 11822-4330-2 UPC 0 11822 43300 6 Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 1701; x) Signature Care NDC 21130-709-38 UPC 3 21130 77915 5 Distributed By: Better Living Brands LLC P.O. Box 99, Pleasanton, CA 94566-0009; y) Sound Body UPC 0 72785 11479 1 Manufactured for Big Lots by: Vi-Jon, Inc. 8515 Page Avenue; St. Louis, MO 63114; z) Sunmark NDC 70677-0051-1 UPC 0 10939 90844 5 Distributed By McKesson One Post Street, San Francisco, CA 94104 or Distributed by McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141; aa) Swan NDC 0869-0166-38 UPC 0 72785 13405 8 Distributed by: Vi-Jon, Inc. One Swan Drive Smyrna, TN 37167; bb) Topcare health UPC 0 36800 45529 0 Distributed By Topco Associates, LLC. Elk Grove Village, IL 60007; cc) Up & Up NDC 11673-708-38 or NDC 11673-666-38 UPC 0 72785 12883 5 Dist. by Target Corp., Mpls., MN 55403; dd) Walgreens NDC 0363-8166-38 UPC 3 11917 20160 3 Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015
Package NDCs: 41163-709-38; 49035-506-38; 50804-166-38; 62011-0380-1; 30142-899-38; 70000-0424-1; 0904-6787-44; 41250-708-38; 56062-266-38; 11822-4330-2; 21130-709-38; 70677-0051-1; 0869-0166-38; 11673-708-38; 0363-8166-38; 0869-7403-08; 11673-666-38
CGMP DeviationsVi-Jon, LLC / 22,965,330 bottlesClass IIOngoing
D-1503-202207-15-2022Kroger, Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), Distributed By The Kroger CO Cincinnati, Ohio 45202; NDC 30142-899-38 UPC 0 41260 00182 6
Package NDCs: 30142-899-38
Microbial contamination of non-sterile products.Vi-Jon, LLC / 44,976 bottlesClass IOngoing
D-1506-202207-15-2022Rexall, Magnesium Citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Distributed By Dolgencorp. LLC 100 Mission Ridge, Goodlettsville, TN 37072 or Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072; NDC 55910-183-38, UPC 0 72785 13418 8
Package NDCs: 55910-183-38
Microbial contamination of non-sterile products.Vi-Jon, LLC / 42,912 bottlesClass IOngoing
D-1513-202207-15-2022Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Grape Flavor, 10 FL OZ (296 mL), a) Best Choice UPC 0 70038 66220 4 Proudly Distributed By: Valu Merchandisers, Co. 5000 Kansas Ave Kansas City, KS 66106; b) CVS Health UPC 0 50428 30745 8 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, CVS Health UPC 0 50428 32503 2 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; c) Equate NDC 49035-592-38 UPC 6 81131 28715 9 Distributed By: Walmart, Inc. Bentonville, AR 72716; d) HEB UPC 0 41220 51088 7 Made With Pride & Care For H-E-B San Antonio, TX 78204; Kroger UPC 0 41260 00871 9 Distributed By The Kroger Co. Cincinnati, Ohio 45202; e) Leader NDC 70000-0576-1 UPC 0 96295 14105 4 Distributed By Cardinal Health Dublin, Ohio 43017; f) Rexall UPC 0 72785 13417 1 Distributed By Dolgencorp, LLC 100 Mission Ridge Goodlettsville, TN 37072 USA, Rexall UPC 0 72785 13417 1 Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072; g) Walgreens NDC 0363-7162-38 UPC 3 11917 20159 7 Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 (purple label), Walgreens NDC 0363-7162-38 UPC 3 11917 20159 7 Distributed By: Walgreen Co. 200 Wilmot RD., Deerfield, IL 60015 (blue label)
Package NDCs: 49035-592-38; 70000-0576-1; 0363-7162-38
CGMP Deviations;Vi-Jon, LLC / 8,064,834Class IIOngoing
D-1358-202207-15-2022Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.Aire-Master of America Inc / 960 cartonsClass IIOngoing
D-1356-202207-15-2022Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.Aire-Master of America Inc / 9,176 cartonsClass IIOngoing
D-1357-202207-15-2022Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.Aire-Master of America Inc / 4,632 cartonsClass IIOngoing
D-1360-202207-15-2022Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.Aire-Master of America Inc / 4 totesClass IIOngoing
D-1351-202207-15-2022Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus Pharmaceuticals (USA ) Inc.m Pennington, NJ 08534, NDC 70710-1688-8.
Package NDCs: 70710-1688-2; 70710-1688-8
Failed Impurities/Degradation SpecificationsZydus Pharmaceuticals (USA) Inc / 1116 boxesClass IIOngoing
D-1502-202207-15-2022EQUALINE magnesium citrate saline laxative, oral solution, (1.745 g/fl oz), DYE FREE lemon flavor, 10 FL OZ (296 mL), Distributed by Supervalu Inc. Eden Prairie, MN 55344 USA, or Distributed By UNFI Providence, RI 02908, NDC 41163-769-38 UPC 0 41163 50068 6
Package NDCs: 41163-769-38
Microbial contamination of non-sterile products.Vi-Jon, LLC / 5,304 bottlesClass IOngoing
D-1507-202207-15-2022SWAN, Citroma MAGNESIUM CITRATE, Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemony Flavor, 10 FL OZ (296 mL), Distributed by: Vi-Jon, Inc. One Swan Drive Smyrna, TN 37167; NDC 0869-0166-38 UPC 0 72785 13405 8
Package NDCs: 0869-0166-38
Microbial contamination of non-sterile products.Vi-Jon, LLC / 27,612 bottlesClass IOngoing
D-1510-202207-15-2022Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Grape Flavor, 10 FL OZ (296 mL), Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015; NDC 0363-7162-38 UPC 3 11917 20159 7 (purple label).
Package NDCs: 0363-7162-38
Microbial contamination of non-sterile products.Vi-Jon, LLC / 29,388 bottlesClass IOngoing
D-1500-202207-15-2022CVS Health, Magnesium Citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), a) UPC 0 50428 30594 2; b) UPC 0 50428 33517 8; Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.Microbial contamination of non-sterile products.Vi-Jon, LLC / 241,086 bottlesClass IOngoing
D-1505-202207-15-2022P, magnesium citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Distributed By Publix Super Markets, Inc. 3300 Publix Corporate Parkway, Lakeland, FL 33811; NDC 56062-266-38 UPC 0 41415 50673 2
Package NDCs: 56062-266-38
Microbial contamination of non-sterile products.Vi-Jon, LLC / 8,682 bottlesClass IOngoing
D-1509-202207-15-2022Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-8166-38 UPC 3 11917 20160 3 (green label)
Package NDCs: 0363-8166-38
Microbial contamination of non-sterile products.Vi-Jon, LLC / 29,172 bottlesClass IOngoing
D-1504-202207-15-2022meijer, magnesium citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544; NDC 41250-708-38 UPC 7 13733 45945 7
Package NDCs: 41250-708-38
Microbial contamination of non-sterile products.Vi-Jon, LLC / L 22,965,330 C 10,070,526 G 8,064,834Class IOngoing
D-1508-202207-15-2022Topcare health, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Cherry Flavor, 10 FL OZ (296 mL), Distributed By Topco Associates LLC Elk Grove Village, IL 60007; NDC 36800-164-38 UPC 0 36800 45530 6
Package NDCs: 36800-164-38
Microbial contamination of non-sterile products.Vi-Jon, LLC / 18,588 bottlesClass IOngoing
D-1283-202207-14-2022Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34, Verna Industrial area, Verna - Goa, 403722, India; Mfd. for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-341-35.
Package NDCs: 69097-341-35
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.CIPLA / 8,136 bottlesClass IIOngoing
D-1288-202207-13-2022Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856179, NDC 43598-561-78
Package NDCs: 43598-560-79; 43598-560-78; 43598-561-79; 43598-561-78; 4359856179
FAILED DISSOLUTION SPECIFICATIONSDr. Reddy's Laboratories, Inc. / 2,639 cartonsClass IIOngoing
D-1301-202207-13-2022Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
Package NDCs: 0409-4699-50; 0409-4699-30; 0409-4699-53; 0409-4699-33; 0409-4699-54; 0409-4699-24; 0409-6010-02; 0409-6010-25
Presence of particulate matter: particulate identified as a beetle.Pfizer Inc. / 54,000 vialsClass IOngoing
D-1287-202207-13-2022Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856079, NDC 43598-560-78
Package NDCs: 43598-560-79; 43598-560-78; 43598-561-79; 43598-561-78; 4359856079
FAILED DISSOLUTION SPECIFICATIONSDr. Reddy's Laboratories, Inc. / 2,892 cartonsClass IIOngoing
D-1309-202207-11-2022Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01
Package NDCs: 0641-6048-01; 0641-6048-25; 0641-6050-01; 0641-6050-10; 0641-6049-01; 0641-6049-25; 0641-6051-01; 0641-6051-10
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.Hikma Pharmaceuticals USA Inc. / 713,550 vialsClass IIOngoing
D-1310-202207-11-2022Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# NDC# 0641-6045-25, Vial NDC# 0641-6045-01
Package NDCs: 0641-6044-01; 0641-6044-25; 0641-6046-01; 0641-6046-10; 0641-6045-01; 0641-6045-25; 0641-6047-01; 0641-6047-10
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.Hikma Pharmaceuticals USA Inc. / 82,700 vialsClass IIOngoing
D-1307-202207-11-2022Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6044-25, Vial NDC# 0641-6044-01
Package NDCs: 0641-6044-01; 0641-6044-25; 0641-6046-01; 0641-6046-10; 0641-6045-01; 0641-6045-25; 0641-6047-01; 0641-6047-10
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.Hikma Pharmaceuticals USA Inc. / 4,739,000 vialsClass IIOngoing
D-1308-202207-11-2022Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01
Package NDCs: 0641-6001-01; 0641-6001-25; 0641-6000-01; 0641-6000-10; 0641-6003-01; 0641-6003-25; 0641-6002-01; 0641-6002-10
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.Hikma Pharmaceuticals USA Inc. / 301,400 vialsClass IIOngoing
D-1300-202207-11-2022Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g tube (NDC 0115-1510-63), c) Net Wt. 60g tube (NDC 0115-1510-58), Rx only, Manufactured by: Tolmar, Inc., Fort Collins, CO, 80526, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
Package NDCs: 0115-1510-63; 0115-1510-58; 0115-1510-48
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention TimeTolmar, Inc. / 1271 tubesClass IIOngoing
D-1304-202207-11-2022Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.
Package NDCs: 68462-534-35; 68462-534-65; 68462-534-94
Defective Container: Tube split from side seamGlenmark Pharmaceuticals Inc., USA / 654,756 tubesClass IIIOngoing
D-1290-202207-08-2022Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.243% sodium fluoride, Net Wt. 5.6 oz (158 g) a) Individual carton, UPC 0 37000 598534; b) 5-count Bundle, UPC 037000171867, Distributed. By Procter & Gamble, Cincinnati, OH 45202.Labeling: Missing label: the product tube was missing a label and contained a different formulation.The Procter & Gamble Company / 1,128 tubesClass IIIOngoing
D-1285-202207-07-2022Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
Package NDCs: 60505-3075-3; 60505-3075-8; 60505-2673-3; 60505-2673-8; 60505-2673-0; 60505-2674-3; 60505-2674-8; 60505-2674-0; 60505-2675-3; 60505-2675-8; 60505-2675-0; 60505-2676-3; 60505-2676-8; 60505-2676-0; 60505-2677-3; 60505-2677-8; 60505-2677-0
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.Apotex Corp. / 2010 bottlesClass IIOngoing
D-1292-202207-05-2022Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specialty L.P., Morgantown, WV
Package NDCs: 49502-394-71; 49502-394-75; 49502-393-80
Labeling: Missing label: Label missing from some prefilled pens.Mylan Pharmaceuticals Inc / 253,200 pens (50,650/5 per packs)Class IOngoing
D-1267-202206-30-2022Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x 2 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-02Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 43,385 syringesClass IIOngoing
D-1247-202206-30-20220.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Ext., West Columbia, SC 29172, NDC: 69374-970-50Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 6900 syringesClass IIOngoing
D-1276-202206-30-2022Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 464,265 syringesClass IIOngoing
D-1277-202206-30-2022Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 6340 syringesClass IIOngoing
D-1249-202206-30-2022Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine HCl 60 mg (1.2 mg/mL) Injection, 50 mL syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-514-50Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 2315 syringesClass IIOngoing
D-1252-202206-30-2022Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 9410 bagsClass IIOngoing
D-1266-202206-30-2022Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-30Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 8985 syringesClass IIOngoing
D-1253-202206-30-2022Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 3690 syringesClass IIOngoing
D-1251-202206-30-2022EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925-10Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 134,385 syringesClass IIOngoing
D-1256-202206-30-2022HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-529-30Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 12,900 syringesClass IIOngoing
D-1248-202206-30-20220.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-947-50Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 1380 syringesClass IIOngoing
D-1262-202206-30-2022Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 184,370 syringesClass IIOngoing
D-1271-202206-30-2022Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-942-04Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 10,700 syringesClass IIOngoing
D-1264-202206-30-2022Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-985-05Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 37,310 syringesClass IIOngoing
D-1268-202206-30-2022Morphine Sulfate Injection, USP, 1 mg/mL syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-01Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 4620 syringesClass IIOngoing
D-1270-202206-30-2022Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-932-03Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 59,520 syringesClass IIOngoing
D-1258-202206-30-2022HYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-50Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 3740 syringesClass IIOngoing
D-1263-202206-30-2022Lidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 64,380 syringesClass IIOngoing
D-1265-202206-30-2022Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-50Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 5495 syringesClass IIOngoing
D-1278-202206-30-2022Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-515-50Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 2210 syringesClass IIOngoing
D-1269-202206-30-2022del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-984-10Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 1765 bagsClass IIOngoing
D-1255-202206-30-2022HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-529-50Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 22,805 syringesClass IIOngoing
D-1272-202206-30-2022Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-902-05Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 64,365 syringesClass IIOngoing
D-1257-202206-30-2022HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-30Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 18,570 syringesClass IIOngoing
D-1245-202206-30-2022Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172, NDC: 69374-988-10Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 163 bagsClass IIOngoing
D-1275-202206-30-2022Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 18,930 syringesClass IIOngoing
D-1274-202206-30-2022Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 75,630 syringesClass IIOngoing
D-1279-202206-30-20228.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syringe per carton, 30 x 1 syringe carton per case, Rx Only Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50Lack of Assurance of SterilityNephron Sterile Compounding Center LLC / 36,354 syringesClass IIOngoing