🍔 Food 💊 Drugs 🏥 Medical Devices
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19 Class II

Reason: Failed Stability Specification

Lupin Pharmaceuticals Inc. 20220427 Terminated
Distributed: Product was distributed nationwide, including Puerto Rico.
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Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017 Class II

Reason: CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.

Pfizer Inc. 20220422 Terminated
Distributed: Nationwide and Puerto Rico
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Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017 Class II

Reason: CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.

Pfizer Inc. 20220422 Terminated
Distributed: Nationwide and Puerto Rico
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Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017 Class II

Reason: CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.

Pfizer Inc. 20220422 Terminated
Distributed: Nationwide and Puerto Rico
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Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73. Class II

Reason: CGMP Deviations: Failure to properly investigate failed microbial testing.

Plastikon Healthcare LLC 20220324 Completed
Distributed: Distributed in Indiana for further distribution in the USA.
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MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73. Class II

Reason: CGMP Deviations: Failure to properly investigate failed microbial testing.

Plastikon Healthcare LLC 20220324 Completed
Distributed: Distributed in Indiana for further distribution in the USA.
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Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76. Class II

Reason: CGMP Deviations: Failure to properly investigate failed microbial testing.

Plastikon Healthcare LLC 20220324 Completed
Distributed: Distributed in Indiana for further distribution in the USA.
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Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distribute by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73. Class I

Reason: Microbial Contamination of Non-Sterile Products

Plastikon Healthcare LLC 20220324 Completed
Distributed: Distributed in Indiana for further distribution in the USA.
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MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73. Class I

Reason: Microbial Contamination of Non-Sterile Products

Plastikon Healthcare LLC 20220324 Completed
Distributed: Distributed in Indiana for further distribution in the USA.
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Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-43 Class III

Reason: Subpotent Drug

Fagron, Inc 20220304 Terminated
Distributed: Nationwide within the USA
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