Two lots of Purely Soothing eye drops have been recalled “due to non-sterility,” that could lead to the risk of eye infections that could result in blindness, the FDA recently announced.
According to a news release, Pharmedica USA LLC is voluntarily recalling the two lots of “Purely Soothing, 15% MSM Drops to the consumer level.”
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The FDA said to date, Pharmedica USA LLC has not received any reports of adverse events or illness related to this recalled product.
The product was distributed worldwide via online e-commerce and trade shows, according to the release.
The FDA’s statement read in part, “The eye drop is used as an anti-inflammatory aimed to assist with symptoms of ocular irritation and/or swelling and is packaged in white, cylindrical HDPE bottles. The eye drops (LOT#: 2203PS01, 1 oz, UPC 7 31034 91379 9; and LOT#: 1808051, ½ oz, UPC 7 31034 91382 9) have eye dropper caps and white lids.”
Consumers with questions regarding this recall can contact Pharmedica USA LLC by phone number at +1 (623) 698 - 1752 or e-mail address at osm@pharmedicausa.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
The recall comes around the same time that other eye drop recalls were announced by the FDA.
The FDA posted separate recall notices for certain eye drops distributed by Pharmedica and Apotex after the companies said they are voluntarily pulling several lots of their products from the market. Both companies said the recalls were conducted in consultation with the FDA.
In February, the FDA also announced that eye drops sold under the name EzriCare and is made in India by Global Pharma Healthcare were recalled after being linked to an outbreak of drug-resistant infections.
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