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-1350-2022 | 07-21-2022 | SUSTANGO (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 cartons | Class I | Terminated |
| D-1329-2022 | 07-20-2022 | Lamotrigine 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 Strength | AVKARE Inc. / 8328 bottles | Class III | Terminated |
| D-1330-2022 | 07-19-2022 | Prednisone 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 Tablets | Strides Pharma Inc. / 1032 bottles | Class II | Terminated |
| D-1474-2022 | 07-19-2022 | Luxury 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 alcohol | Tsm Brands LLC / 2,700,000 bottles | Class II | Ongoing |
| D-1475-2022 | 07-19-2022 | Luxury 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 alcohol | Tsm Brands LLC / 350,000 bottles | Class II | Ongoing |
| D-1294-2022 | 07-18-2022 | Irbesartan 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 Specifications | Jubilant Cadista Pharmaceuticals, Inc. / 28,560 bottles | Class II | Terminated |
| D-1293-2022 | 07-18-2022 | Irbesartan 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 bottles | Class II | Terminated |
| D-1507-2022 | 07-15-2022 | SWAN, 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 | Microbial contamination of non-sterile products. | Vi-Jon, LLC / 27,612 bottles | Class I | Terminated |
| D-1501-2022 | 07-15-2022 | equate 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 | Microbial contamination of non-sterile products. | Vi-Jon, LLC / 18,324 bottles | Class I | Terminated |
| D-1513-2022 | 07-15-2022 | Magnesium 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) | CGMP Deviations; | Vi-Jon, LLC / 8,064,834 | Class II | Terminated |
| D-1509-2022 | 07-15-2022 | Walgreens, 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) | Microbial contamination of non-sterile products. | Vi-Jon, LLC / 29,172 bottles | Class I | Terminated |
| D-1504-2022 | 07-15-2022 | meijer, 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 | Microbial contamination of non-sterile products. | Vi-Jon, LLC / L 22,965,330 C 10,070,526 G 8,064,834 | Class I | Terminated |
| D-1351-2022 | 07-15-2022 | Fulvestrant 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 Specifications | Zydus Pharmaceuticals (USA) Inc / 1116 boxes | Class II | Terminated |
| D-1503-2022 | 07-15-2022 | Kroger, 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 bottles | Class I | Terminated |
| D-1511-2022 | 07-15-2022 | Magnesium 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; 50804-166-38; 30142-899-38; 56062-266-38; 11822-4330-2; 21130-709-38; 11673-708-38; 0869-7403-08; 49035-506-38; 62011-0380-1; 70000-0424-1; 0904-6787-44; 41250-708-38; 70677-0051-1; 0869-0166-38; 11673-666-38; 0363-8166-38 | CGMP Deviations | Vi-Jon, LLC / 22,965,330 bottles | Class II | Terminated |
| D-1508-2022 | 07-15-2022 | Topcare 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 bottles | Class I | Terminated |
| D-1502-2022 | 07-15-2022 | EQUALINE 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 bottles | Class I | Terminated |
| D-1505-2022 | 07-15-2022 | P, 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 bottles | Class I | Terminated |
| D-1506-2022 | 07-15-2022 | Rexall, 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 bottles | Class I | Terminated |
| D-1510-2022 | 07-15-2022 | Walgreens, 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). | Microbial contamination of non-sterile products. | Vi-Jon, LLC / 29,388 bottles | Class I | Terminated |
| D-1512-2022 | 07-15-2022 | Magnesium 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; 50804-164-38; 56062-264-38; 21130-165-38; 36800-164-38; 49035-593-38; 56319-164-38; 62011-0381-1; 70000-0575-1; 70000-0576-1; 41250-769-38; 11822-4303-2; 70677-0053-1; 0869-0164-38; 0363-8164-38 | CGMP Deviations | Vi-Jon, LLC / 10,070,526 | Class II | Terminated |
| D-1359-2022 | 07-15-2022 | Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606 | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. | Aire-Master of America Inc / 5,064 bottles | Class II | Terminated |
| D-1355-2022 | 07-15-2022 | Avant 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 62253 | CGMP 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 drums | Class II | Terminated |
| D-1360-2022 | 07-15-2022 | Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734 | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. | Aire-Master of America Inc / 4 totes | Class II | Terminated |
| D-1356-2022 | 07-15-2022 | Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253 | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. | Aire-Master of America Inc / 9,176 cartons | Class II | Terminated |
| D-1358-2022 | 07-15-2022 | Protect 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 cartons | Class II | Terminated |
| D-1357-2022 | 07-15-2022 | Stage 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 60440 | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. | Aire-Master of America Inc / 4,632 cartons | Class II | Terminated |
| D-1500-2022 | 07-15-2022 | CVS 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 bottles | Class I | Terminated |
| D-1283-2022 | 07-14-2022 | Difluprednate 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 bottles | Class II | Terminated |
| D-1301-2022 | 07-13-2022 | Propofol 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; 0409-1511-97; 0409-1511-98; 0409-0501-97; 0409-0501-98; 0409-0010-97; 0409-0010-98 | Presence of particulate matter: particulate identified as a beetle. | Pfizer Inc. / 54,000 vials | Class I | Terminated |
| D-1288-2022 | 07-13-2022 | Lansoprazole 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 | FAILED DISSOLUTION SPECIFICATIONS | Dr. Reddy's Laboratories, Inc. / 2,639 cartons | Class II | Terminated |
| D-1287-2022 | 07-13-2022 | Lansoprazole 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 | FAILED DISSOLUTION SPECIFICATIONS | Dr. Reddy's Laboratories, Inc. / 2,892 cartons | Class II | Terminated |
| D-1308-2022 | 07-11-2022 | Ativan 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 | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. | Hikma Pharmaceuticals USA Inc. / 301,400 vials | Class II | Terminated |
| D-1300-2022 | 07-11-2022 | Naftifine 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 | Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time | Tolmar, Inc. / 1271 tubes | Class II | Terminated |
| D-1304-2022 | 07-11-2022 | Tacrolimus 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; 68462-881-35; 68462-881-65; 68462-881-94 | Defective Container: Tube split from side seam | Glenmark Pharmaceuticals Inc., USA / 654,756 tubes | Class III | Ongoing |
| D-1307-2022 | 07-11-2022 | Lorazepam 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 vials | Class II | Terminated |
| D-1309-2022 | 07-11-2022 | Lorazepam 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 vials | Class II | Terminated |
| D-1310-2022 | 07-11-2022 | Lorazepam 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 vials | Class II | Terminated |
| D-1290-2022 | 07-08-2022 | Crest 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 tubes | Class III | Completed |
| D-1285-2022 | 07-07-2022 | Aripiprazole 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 | Failed dissolution specifications: OOS for dissolution at the 12-month stability time point. | Apotex Corp. / 2010 bottles | Class II | Terminated |
| D-1292-2022 | 07-05-2022 | Insulin 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 | Labeling: Missing label: Label missing from some prefilled pens. | Mylan Pharmaceuticals Inc / 253,200 pens (50,650/5 per packs) | Class I | Terminated |
| D-1279-2022 | 06-30-2022 | 8.4% 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: 69374-214-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 36,354 syringes | Class II | Terminated |
| D-1247-2022 | 06-30-2022 | 0.125% 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: 69374-970-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 6900 syringes | Class II | Terminated |
| D-1275-2022 | 06-30-2022 | Phenylephrine 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: 69374-956-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 18,930 syringes | Class II | Terminated |
| D-1259-2022 | 06-30-2022 | Ketamine HCl Injection, USP, 50 mg/5 mL (10 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: 69374-982-55 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 91,445 syringes | Class II | Terminated |
| D-1260-2022 | 06-30-2022 | Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, 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: 69374-982-33 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 30,745 syringes | Class II | Terminated |
| D-1254-2022 | 06-30-2022 | Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, 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: 69374-903-30 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 3450 syringes | Class II | Terminated |
| D-1261-2022 | 06-30-2022 | Ketamine HCl Injection, USP, 50 mg/1 mL (50 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: 69374-511-01 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 47,905 syringes | Class II | Terminated |
| D-1278-2022 | 06-30-2022 | Ropivacaine 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: 69374-515-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 2210 syringes | Class II | Terminated |
| D-1272-2022 | 06-30-2022 | Neostigmine 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: 69374-902-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 64,365 syringes | Class II | Terminated |
| D-1257-2022 | 06-30-2022 | HYDROmorphone 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: 69374-559-30 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 18,570 syringes | Class II | Terminated |
| D-1264-2022 | 06-30-2022 | Lidocaine 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: 69374-985-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 37,310 syringes | Class II | Terminated |
| D-1250-2022 | 06-30-2022 | EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 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: 69374-544-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 19,060 syringes | Class II | Terminated |
| D-1265-2022 | 06-30-2022 | Morphine 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: 69374-979-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 5495 syringes | Class II | Terminated |
| D-1248-2022 | 06-30-2022 | 0.9% 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: 69374-947-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 1380 syringes | Class II | Terminated |
| D-1280-2022 | 06-30-2022 | Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 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: 69374-906-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 85,300 syringes | Class II | Terminated |
| D-1281-2022 | 06-30-2022 | Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/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: 69374-919-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 18,840 syringes | Class II | Terminated |
| D-1276-2022 | 06-30-2022 | Phenylephrine 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: 69374-957-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 464,265 syringes | Class II | Terminated |
| D-1267-2022 | 06-30-2022 | Morphine 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: 69374-979-02 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 43,385 syringes | Class II | Terminated |
| D-1253-2022 | 06-30-2022 | Glycopyrrolate 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: 69374-903-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 3690 syringes | Class II | Terminated |
| D-1277-2022 | 06-30-2022 | Rocuronium 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: 69374-924-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 6340 syringes | Class II | Terminated |
| D-1273-2022 | 06-30-2022 | Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-543-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 1810 bags | Class II | Terminated |
| D-1274-2022 | 06-30-2022 | Phenylephrine 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: 69374-955-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 75,630 syringes | Class II | Terminated |
| D-1246-2022 | 06-30-2022 | Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 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 Street Extension, West Columbia, SC 29172, NDC: 69374-935-03 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 13,340 syringes | Class II | Terminated |
| D-1270-2022 | 06-30-2022 | Neostigmine 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: 69374-932-03 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 59,520 syringes | Class II | Terminated |
| D-1245-2022 | 06-30-2022 | Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172, NDC: 69374-988-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 163 bags | Class II | Terminated |
| D-1251-2022 | 06-30-2022 | EPINEPHrine 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: 69374-925-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 134,385 syringes | Class II | Terminated |
| D-1255-2022 | 06-30-2022 | HYDROmorphone 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: 69374-529-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 22,805 syringes | Class II | Terminated |
| D-1249-2022 | 06-30-2022 | Bupivacaine 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: 69374-514-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 2315 syringes | Class II | Terminated |
| D-1263-2022 | 06-30-2022 | Lidocaine 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: 69374-949-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 64,380 syringes | Class II | Terminated |
| D-1266-2022 | 06-30-2022 | Morphine 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: 69374-979-30 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 8985 syringes | Class II | Terminated |
| D-1271-2022 | 06-30-2022 | Neostigmine 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: 69374-942-04 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 10,700 syringes | Class II | Terminated |
| D-1252-2022 | 06-30-2022 | Fentanyl 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: 69374-523-21 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 9410 bags | Class II | Terminated |
| D-1268-2022 | 06-30-2022 | Morphine 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: 69374-979-01 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 4620 syringes | Class II | Terminated |
| D-1258-2022 | 06-30-2022 | HYDROmorphone 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: 69374-559-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 3740 syringes | Class II | Terminated |
| D-1256-2022 | 06-30-2022 | HYDROmorphone 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: 69374-529-30 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 12,900 syringes | Class II | Terminated |
| D-1269-2022 | 06-30-2022 | del 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: 69374-984-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 1765 bags | Class II | Terminated |
| D-1262-2022 | 06-30-2022 | Labetalol 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: 69374-946-04 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 184,370 syringes | Class II | Terminated |
| D-1171-2022 | 06-29-2022 | Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / 36 bottles | Class II | Terminated |
| D-1311-2022 | 06-29-2022 | Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibiotic Ointment, 144 packets per box, Net wt. per packet 0.5 g, Honeywell Safety Products, NDC 0498-0750-36. | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 6 boxes | Class II | Terminated |
| D-1299-2022 | 06-29-2022 | Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566 | Failed Dissolution Specifications | Eco Lips, Inc / 35,313 tubes | Class III | Terminated |
| D-1289-2022 | 06-29-2022 | Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30 Package NDCs: 0591-2921-18; 0591-2921-02; 0591-3216-17; 0591-3216-30; 0591-3217-26; 0591-3217-30 | Superpotent Drug: Out of specification assay result was obtained during stability testing. | Teva Pharmaceuticals USA Inc / 12354 cartons | Class II | Terminated |
| D-1315-2022 | 06-29-2022 | Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04. | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 16 boxes | Class II | Terminated |
| D-1319-2022 | 06-29-2022 | Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Healthcare Pharmaceuticals, NDC 11523-7234-4. Package NDCs: 11523-7268-3; 11523-7268-8; 11523-7268-7; 11523-7268-4; 11523-7268-9; 11523-7268-5; 11523-7234-1; 11523-7234-2; 11523-7234-3; 11523-7234-4; 11523-7234-5; 11523-7234-6; 11523-7234-9; 11523-7341-1; 11523-7341-2; 11523-4357-1; 11523-4357-3; 11523-4357-5; 11523-4357-2; 1152372340 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 67 bottles | Class II | Terminated |
| D-1327-2022 | 06-29-2022 | Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, Manufactured for: Dynarex Corporation, NY 10962, Made in Mexico, NDC 67777-300-01 (current NDC) NDC# 67777-120-10 (discontinued) Package NDCs: 67777-300-01; 67777-300-02; 67777-120-10 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / | Class II | Terminated |
| D-1326-2022 | 06-29-2022 | Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16. Package NDCs: 67777-121-14; 67777-121-19; 67777-121-20; 67777-121-16; 67777-121-17; 67777-121-18; 67777-121-13; 67777-121-11; 67777-121-12; 67777-121-27; 67777-121-26; 67777-121-21; 67777-121-22; 67777-121-23; 67777-121-24 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 10 boxes | Class II | Terminated |
| D-1323-2022 | 06-29-2022 | Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 0436-0936-16, c) sodium hypochlorite 0.5% full strength, NDC 0436-0946-16, Antimicrobial, 473 mL (16 fl oz) bottle, Century Pharmaceuticals, Inc. Package NDCs: 0436-0672-16; 0436-0936-16; 0436-0946-16 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 113 bottles | Class II | Terminated |
| D-1298-2022 | 06-29-2022 | Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566 | Failed Dissolution Specifications | Eco Lips, Inc / 15,313 tubes | Class III | Terminated |
| D-1318-2022 | 06-29-2022 | Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01. Package NDCs: 63029-321-01; 63029-321-02; 0420371047 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 131 boxes | Class II | Terminated |
| D-1316-2022 | 06-29-2022 | Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) bottle per box, Alcon, NDC 0065-1433-02. Package NDCs: 0065-1433-02; 0065-1433-07; 0065-1433-11; 0065143302 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 12 boxes | Class II | Terminated |
| D-1312-2022 | 06-29-2022 | Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01. Package NDCs: 57896-443-66; 57896-443-12; 57896-443-55; 57896-443-05; 57896-443-01 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 45 boxes | Class II | Terminated |
| D-1324-2022 | 06-29-2022 | Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01. | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 1 box | Class II | Terminated |
| D-1306-2022 | 06-29-2022 | Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc,m USA, Mahwah, NJ 07430, NDC 68462-841-13. Package NDCs: 68462-840-13; 68462-841-13; 68462-842-13 | Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister . | Glenmark Pharmaceuticals Inc., USA / | Class II | Terminated |
| D-1305-2022 | 06-29-2022 | Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430, NDC 68462-842-13. Package NDCs: 68462-840-13; 68462-841-13; 68462-842-13 | Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister . | Glenmark Pharmaceuticals Inc., USA / 72288 units | Class II | Terminated |
| D-1321-2022 | 06-29-2022 | Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Sterile, 2.5 mL (0.085 FL OZ) bottle per box, Alcon, NDC 0065-8150-01. Package NDCs: 0065-8150-01; 0065-8150-03; 0065-8150-04; 0065-8150-07; 0006581500 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 1 box | Class II | Terminated |
| D-1325-2022 | 06-29-2022 | Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99. Package NDCs: 0487-5901-99 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 23 cartons | Class II | Terminated |
| D-1282-2022 | 06-29-2022 | Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-405-60. Package NDCs: 68462-405-60; 68462-405-30 | Failed Tablet/Capsule Specification : Capsule breakage | Glenmark Pharmaceuticals Inc., USA / 168936 bottles | Class III | Ongoing |
| D-1313-2022 | 06-29-2022 | Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0.5 FL OZ) bottle per box, Alcon, a Novartis company, NDC 0065-0085-15. Package NDCs: 0065-0085-15; 0065-0085-38; 0065-0085-42; 0065-0085-52; 0065008515 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 12 boxes | Class II | Terminated |
| D-1317-2022 | 06-29-2022 | Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box, Alcon, NDC 0065-4011-05. Package NDCs: 0065-4011-05; 0065-4011-06; 0065-4011-11; 0065401105 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 9 boxes | Class II | Terminated |
| D-1314-2022 | 06-29-2022 | Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc. Package NDCs: 0065-0429-15; 0065-0429-21; 0065-0429-30; 0065-0429-36; 0065-0429-67; 0065042915; 0065042930 | CGMP Deviations: products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 47 bottles | Class II | Terminated |
