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FDA Recalls

Showing 3,491–3,500 of 18,043 recalls

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🍔 Food 💊 Drugs 🏥 Medical Devices

Sodium 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 Class II

Reason: 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.

Akorn, Inc. 20220831 Terminated

Distributed: USA nationwide

Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31 Class II

Reason: 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.

Akorn, Inc. 20220831 Terminated

Distributed: USA nationwide

CORRECTDOSE 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 Class II

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Plastikon Healthcare LLC 20220607 Terminated

Distributed: Distributed Nationwide in the USA

CORRECTDOSE 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 Class II

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Plastikon Healthcare LLC 20220607 Terminated

Distributed: Distributed Nationwide in the USA

CORRECTDOSE 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 Class II

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Plastikon Healthcare LLC 20220607 Terminated

Distributed: Distributed Nationwide in the USA

GUAIFENESIN 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 Class II

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Plastikon Healthcare LLC 20220607 Terminated

Distributed: Distributed Nationwide in the USA

GUAIFENESIN 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 Class II

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Plastikon Healthcare LLC 20220607 Terminated

Distributed: Distributed Nationwide in the USA

Diphenhydramine 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 Class II

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Plastikon Healthcare LLC 20220607 Terminated

Distributed: Distributed Nationwide in the USA

Diphenhydramine 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 Class II

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Plastikon Healthcare LLC 20220607 Terminated

Distributed: Distributed Nationwide in the USA

CALCIUM 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 Class II

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Plastikon Healthcare LLC 20220607 Terminated

Distributed: Distributed Nationwide in the USA

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