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Camolyn eye drops, Fisiolin nasal drops: Voluntary recall due to non-sterility
Audience: Consumers, Pharmacists
US Oftalmi and FDA notified healthcare professionals of the nationwide recall of all over-the-counter eye drops and nasal drops, initiated due to conditions at the manufacturing facility that cannot assure the sterility of the products. Products that are non-sterile have the potential to cause eye infections, which may be sight threatening. Products are packaged in 15mL plastic bottles and were distributed nationwide to food and drug distributors. The products affected by this recall with lot numbers, expiration dates and UPC codes are noted in the firm's press release below.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Online: www.fda.gov/MedWatch/report.htm
- Phone: 1-800-332-1088
- Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
- Fax: 1-800-FDA-0178
Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
