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MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. Class II

Reason: Lack of Assurance of Sterility

Carolina Infusion 20220826 Completed
Distributed: Nationwide in the USA.
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L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. Class II

Reason: Lack of Assurance of Sterility

Carolina Infusion 20220826 Completed
Distributed: Nationwide in the USA.
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Bupivacaine 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. Class II

Reason: Lack of Assurance of Sterility

Pine Pharmaceuticals, LLC 20220727 Terminated
Distributed: Product was distributed to direct accounts in AL, CA, NC and NY
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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) Class II

Reason: CGMP Deviations;

Vi-Jon, LLC 20220715 Terminated
Distributed: Distributed Nationwide in the USA as well as Canada and Panama.
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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 Class II

Reason: CGMP Deviations

Vi-Jon, LLC 20220715 Terminated
Distributed: Distributed Nationwide in the USA as well as Canada and Panama.
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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 Class II

Reason: CGMP Deviations

Vi-Jon, LLC 20220715 Terminated
Distributed: Distributed Nationwide in the USA as well as Canada and Panama.
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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). Class I

Reason: Microbial contamination of non-sterile products.

Vi-Jon, LLC 20220715 Terminated
Distributed: Distributed Nationwide in the USA as well as Canada and Panama.
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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) Class I

Reason: Microbial contamination of non-sterile products.

Vi-Jon, LLC 20220715 Terminated
Distributed: Distributed Nationwide in the USA as well as Canada and Panama.
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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 Class I

Reason: Microbial contamination of non-sterile products.

Vi-Jon, LLC 20220715 Terminated
Distributed: Distributed Nationwide in the USA as well as Canada and Panama.
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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 Class I

Reason: Microbial contamination of non-sterile products.

Vi-Jon, LLC 20220715 Terminated
Distributed: Distributed Nationwide in the USA as well as Canada and Panama.
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