Multi-event March 2022 FDA Recall Drug by Plastikon Healthcare Llc

This Multi-event Class II drug recall was voluntarily initiated by Plastikon Healthcare Llc on March 24, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Distributed in Indiana for further distribution in the USA. and the recall is currently completed.

Reported Recall Events

D-0870-2022 COMPLETED D-0868-2022 COMPLETED D-0867-2022 COMPLETED D-0869-2022 COMPLETED D-0871-2022 COMPLETED

Recall Number: D-0870-2022

Reason for Recall
CGMP Deviations: Failure to properly investigate failed microbial testing.
Initiated
03-24-2022
Reported
05-25-2022
Quantity
5,400 Unit Dose cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Plastikon Healthcare LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in Indiana for further distribution in the USA.
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# Lot: 20041A, EXP May 2022

Recall Number: D-0868-2022

Reason for Recall
Microbial Contamination of Non-Sterile Products
Initiated
03-24-2022
Reported
05-25-2022
Quantity
23,300 Unit Dose cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Plastikon Healthcare LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in Indiana for further distribution in the USA.
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# Lot: 21067A, EXP Jun 2023

Recall Number: D-0867-2022

Reason for Recall
Microbial Contamination of Non-Sterile Products
Initiated
03-24-2022
Reported
05-25-2022
Quantity
14,100 Unit Dose cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Plastikon Healthcare LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in Indiana for further distribution in the USA.
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# Lot: 20024A, 20025A, EXP Mar 2022

Recall Number: D-0869-2022

Reason for Recall
CGMP Deviations: Failure to properly investigate failed microbial testing.
Initiated
03-24-2022
Reported
05-25-2022
Quantity
121,800 Unit Dose cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Plastikon Healthcare LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in Indiana for further distribution in the USA.
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# Lot: 20040A, EXP May 2022

Recall Number: D-0871-2022

Reason for Recall
CGMP Deviations: Failure to properly investigate failed microbial testing.
Initiated
03-24-2022
Reported
05-25-2022
Quantity
106,400 Unit Dose cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89879
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Plastikon Healthcare LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in Indiana for further distribution in the USA.
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# Lot: 20042A, 20043A, 20045A, 20046A, 20047A, EXP May 2022