CHICAGO (Reuters) - Johnson & Johnson JNJ.N and Merck & Co MRK.N said on Monday it is recalling about 12,000 bottles of Mylicon infant anti-gas drops in the dye-free variety because they may contain metal fragments.
The companies said they are voluntarily recalling two lots of the over-the-counter medicine as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process.
They said the potential for serious injury is low, and any effects were expected to be temporary and resolved without medical treatment.
J&J and Merck sell the medicine through a 50-50 joint venture.
The recalled products -- Infants’ Mylicon Gas Relief Dye Free (simethicone-antigas) non-staining drops sold in one-ounce plastic bottles -- were distributed nationwide after October 5.
The recall does not affect any Original Infants’ Mylicon Gas Relief products (1/2-ounce or 1-ounce size) or Infants’ Mylicon Gas Relief Dye Free drops non-staining (1/2-ounce size).
Consumers who have purchased Mylicon drops with lot numbers SMF007 or SMF008 should immediately stop using the product and contact the company at 1-800-222-9435. Parents who have given the product to their infants and are concerned should contact their health care provider immediately, the companies said.
Reporting by Susan Kelly; Editing by Bernard Orr
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