Antacid suspension product recalled due to microbial contamination
Plastikon Healthcare LLC is recalling 23,300 antacid suspension cups due to microbial contamination. The product was distributed in Indiana for institutional use.
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 requires minimum severity score of 4. No reported deaths or serious injuries in the source material.
Plain-English summary
Plastikon Healthcare LLC is recalling 23,300 Unit Dose cups of an antacid suspension. The product contains magnesium hydroxide 1200mg, aluminum hydroxide 1200mg, and simethicone 120mg per 30 mL cup. The recalled product is lot 21067A with an expiration date of June 2023, and was distributed in Indiana for further distribution throughout the United States.
The U.S. Food and Drug Administration (FDA) issued this Class I recall due to microbial contamination of the non-sterile product.
This product is intended for institutional use only. Consumers and healthcare facilities in possession of this product should not use it. Contact Plastikon Healthcare LLC or the distributor, Major Pharmaceuticals, for instructions on return or disposal of the recalled product.
The recalled product
- 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.
- Manufacturer
- Plastikon Healthcare LLC
- Category
- Drug — Antacid suspension
- Hazard
- Affected units
- 23,300
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 (2)
- Lot: 21067A
- EXP Jun 2023
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 5 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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