RecallRadar

FDA Drug recall D-1478-2022

Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays pe…

On 2022-09-14 the FDA classified a Class I recall of Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays pe… by Plastikon Healthcare, citing microbial Contamination of Non-Sterile Products.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1478-2022
ClassificationClass I
Statusterminated
Initiated2022-06-07
Published2022-09-14
Last updated2026-09-13 11:52 UTC
CompanyPlastikon Healthcare
DistributionUS

Product

Magnesium 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

Reason

Microbial Contamination of Non-Sterile Products.

Identifiers

code_infoLot# 20076A, EXP Jul. 2022, 20079A, 20081A, EXP Aug. 2022; 21096A, EXP Oct. 2022; 21115A, 21103A, EXP Sep. 2022.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1478-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.