November 10, 2008: Infants' Mylicon Gas Relief Dye-Free Drops Recall

Recall Reason

Johnson & Johnson and Merck Consumer Pharmaceuticals Company, in consultation with the US Food and Drug Administration (FDA), are voluntarily recalling about 12,000 units of their non-staining Infants' Mylicon Gas Relief Dye-Free Drops. (The product is sold over the counter in retail stores and pharmacies as an anti-gas medicine to relieve the discomfort of infant gas frequently caused by air swallowing or by certain formulas or foods.)

According to the companies' press release, some bottles could include metal fragments that were generated during the manufacturing process.

Although the potential for serious medical events is low, Merck and Johnson & Johnson are implementing this recall to the consumer level as a precaution. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their healthcare provider immediately.

Do You Own This Medicine?

Read the official press release here.

The two lots of Infants' Mylicon Gas Relief Dye-Free drops non-staining 1 oz. bottles included in the recall were distributed after October 5, 2008 nationwide. Look for the following:

Product code: 71683791111-1
Lot number: SMF007
Expiration: 09/10

Product code: 71683791111-1
Lot number: SMF008
Expiration: 09/10

(Consumers can find the lot numbers on the bottom of the box containing the product and also on the lower left side of the sticker on the product bottle.)

Note: The recall does not affect any Original Infants' Mylicon Gas Relief products (1/2 oz. or 1 oz. size) or Infants' Mylicon Gas Relief Dye-Free drops non-staining (1/2 oz. size).

Whom to Contact

Consumers who purchased Infants' Mylicon Gas Relief Dye-Free Drops included in this recall should immediately stop using the product and call 1-800-222-9435 (Monday through Friday, 8 AM to 8 PM EST), or visit www.mylicon.com for instructions regarding how to dispose of the product and request a replacement or refund.