FDAClass IIOctober 16, 2019

Major Infants' Gas Relief Drops recall: Sterility Concern

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

Why was Major Infants' Gas Relief Drops recalled?

Microbial Contamination of Non-Sterile Product.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: WBD003 Exp. 03/21

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
Recalling firm
GCP Laboratories Inc
Quantity
31,392 30 mL bottles
Distribution
Distributed in MI and further distributed Nationwide.
Recall date
October 16, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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