Major Infants' Gas Relief Drops Recalled for Microbial Contamination
GCP Laboratories is recalling Major Infants' Gas Relief Drops due to microbial contamination of the non-sterile product.
The agency’s classification
FDA (Drugs): Class II
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.
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: The agency classification is FDA Class II, and the source text explicitly cites microbial contamination, which aligns with the rubric criteria for Severe severity involving significant health risks.
Plain-English summary
GCP Laboratories Inc is recalling Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottles. The recall is due to microbial contamination of the non-sterile product.
The affected product is identified by Lot WBD003 with an expiration date of 03/21. The recall covers 31,392 bottles. The product was distributed in Michigan and further distributed nationwide.
Consumers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA. NDC 0904-5894-30
- Manufacturer
- GCP Laboratories Inc
- Category
- Drug — Infant Medication
- Hazard
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 (1)
- Lot: WBD003 Exp. 03/21
Distribution
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