Antacid Oral Suspension Recalled Nationwide for Microbial Contamination
Plastikon Healthcare LLC is recalling an antacid oral suspension distributed nationwide due to microbial contamination. Affected lots 20051A (exp. Aug. 2022) and 20088A (exp. Sep. 2022) should not be used.
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: This recall carries an FDA Class I designation, the most serious classification, indicating a serious potential hazard. The rubric requires a minimum score of 4 for FDA Class I recalls. No illnesses or deaths have been reported in the source material.
Plain-English summary
Plastikon Healthcare LLC is recalling Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, and Simethicone 240 mg oral suspension in 30 mL cups labeled for institutional use only. The product was distributed nationwide across the United States, with approximately 43,200 cups in circulation.
The recall is due to microbial contamination in the non-sterile formulation. The affected lots are 20051A (expiration August 2022) and 20088A (expiration September 2022).
Institutions and individuals who have received this product should stop using it immediately. Contact your healthcare provider or pharmacist for guidance on alternative treatments. Healthcare facilities should quarantine affected inventory and contact their distributor for return instructions and replacement product.
The recalled product
- Product
- Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 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…
- Manufacturer
- Plastikon Healthcare LLC
- Category
- Drug — Antacid Oral Suspension
- Hazard
- Affected units
- 43,200
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 (4)
- Lot #: 20051A
- EXP Aug. 2022
- 20088A
- 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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