FDA-Drug2020-10-14Class III

Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40

PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Hazard

Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint

Sold states
Nationwide.
Affected count
13480 cups
Manufactured in
1700 Perimeter Rd, N/A, Greenville, SC, United States
Products
Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0015-2021

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