FDA-Device2022-10-05Class III
a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b. DYNAREX Dynarex PETROLEUM JELLY, WHITE 4OZ TU(72/CS) DYNREX Catalog #1145
Mckesson Medical-Surgical Inc. Corporate Office
Hazard
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.
Sold states
US Nationwide distribution.
Affected count
a. 163 bx b. 2.8 cs
Manufactured in
9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, United States
Products
a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b. DYNAREX Dynarex PETROLEUM JELLY, WHITE 4OZ TU(72/CS) DYNREX Catalog #1145
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1808-2022Don't want to check this manually?
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