FDA-Drug2023-05-31Class II
diphenhydrAMINE 50 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7090-1.
Central Admixture Pharmacy Services, Inc.
Hazard
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Sold states
Nationwide in the USA.
Affected count
3999 bags
Manufactured in
6580 Snowdrift Rd Ste 100, N/A, Allentown, PA, United States
Products
diphenhydrAMINE 50 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7090-1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0738-2023Don't want to check this manually?
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