Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-09-21FDA-DrugVi-Jon, LLCClass ISWAN, 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.
- 2022-09-21FDA-DrugVi-Jon, LLCClass IRexall, 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
Microbial contamination of non-sterile products.
- 2022-09-21FDA-DrugVi-Jon, LLCClass IP, 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
Microbial contamination of non-sterile products.
- 2022-09-21FDA-DrugVi-Jon, LLCClass Imeijer, 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.
- 2022-09-21FDA-DrugVi-Jon, LLCClass IKroger, 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
Microbial contamination of non-sterile products.
- 2022-09-21FDA-DrugVi-Jon, LLCClass IEQUALINE 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
Microbial contamination of non-sterile products.
- 2022-09-21FDA-DrugVi-Jon, LLCClass Iequate 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.
- 2022-09-21FDA-DrugVi-Jon, LLCClass ICVS 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.
- 2022-09-21FDA-DrugEdgewell Personal Care Brands, LLCClass IBanana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.0%, Homosalate 6.0%, Octocrylene 6.0%, packaged in Net Wt 6 oz. aluminum spray can, Distributed by: Edgewell Personal Care Brands, LLC, Shelton, CT 06484, UPC 0 79656 04041 8
Chemical contamination: presence of benzene
- 2022-09-14FDA-DrugCIPLAClass IIDifluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 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.
- 2022-09-14FDA-DrugCIPLAClass IIDifluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.
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.
- 2022-09-14FDA-DrugAkorn, Inc.Class IISodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
- 2022-09-14FDA-DrugAkorn, Inc.Class IILidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
- 2022-09-14FDA-DrugPlastikon Healthcare LLCClass IICORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60mL), packaged in 12-5 individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-321-05 UPC 8 60003 67146 7
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- 2022-09-14FDA-DrugPlastikon Healthcare LLCClass IICORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 0
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- 2022-09-14FDA-DrugPlastikon Healthcare LLCClass IICORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-302-05 UPC 8 60003 67144 3
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- 2022-09-14FDA-DrugPlastikon Healthcare LLCClass IIGUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6980-72
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- 2022-09-14FDA-DrugPlastikon Healthcare LLCClass IIGUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152. NDC 0904-6844-70
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- 2022-09-14FDA-DrugPlastikon Healthcare LLCClass IIDiphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6741-72
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- 2022-09-14FDA-DrugPlastikon Healthcare LLCClass IIDiphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6740-70
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- 2022-09-14FDA-DrugPlastikon Healthcare LLCClass IICALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-7098-94
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- 2022-09-14FDA-DrugPlastikon Healthcare LLCClass IIAcetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6820-76
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- 2022-09-14FDA-DrugPlastikon Healthcare LLCClass IIAcetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6739-71
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- 2022-09-14FDA-DrugPlastikon Healthcare LLCClass IIAcetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6738-70
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- 2022-09-14FDA-DrugPlastikon Healthcare LLCClass IIMagnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6839-73
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- 2022-09-14FDA-DrugPlastikon Healthcare LLCClass IIMagnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- 2022-09-14FDA-DrugPlastikon Healthcare LLCClass IIMILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6840-72.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- 2022-09-14FDA-DrugPlastikon Healthcare LLCClass IIMILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6846-73.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
- 2022-09-14FDA-DrugPlastikon Healthcare LLCClass IMagnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6839-73
Microbial Contamination of Non-Sterile Products.
- 2022-09-14FDA-DrugPlastikon Healthcare LLCClass IMagnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73
Microbial Contamination of Non-Sterile Products.
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