Antacid Medication Recalled Nationwide for Microbial Contamination Risk
Plastikon Healthcare LLC is recalling 220,500 cups of antacid containing magnesium hydroxide and aluminum hydroxide due to microbial contamination.
The agency’s classification
FDA (Drugs): Class I
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall classification mandates a minimum severity score of 4 per the rubric. The source does not report any illnesses, injuries, or deaths, which would elevate this to a score of 5 (Critical).
Plain-English summary
Plastikon Healthcare LLC is recalling Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, and Simethicone 120 mg per 30 mL antacid product distributed for institutional use.
The recall is due to microbial contamination identified in the non-sterile product. A total of 220,500 cups have been distributed nationwide. The affected lot numbers are 20076A (expiring July 2022), 20079A and 20081A (expiring August 2022), 21096A (expiring October 2022), and 21115A and 21103A (expiring September 2022).
This is a Class I recall, the most serious FDA classification for drugs.
The recalled product
- 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
- Manufacturer
- Plastikon Healthcare LLC
- Category
- Drug — Antacid
- Hazard
- Affected units
- 220,500
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lot# 20076A
- EXP Jul. 2022
- 20079A
- 20081A
- EXP Aug. 2022
- 21096A
- EXP Oct. 2022
- 21115A
- 21103A
- EXP Sep. 2022.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Plastikon Healthcare LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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