Reported Oct 14, 2020 · Terminated
Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc.…
PAI Holdings, LLC. dba Pharmaceutical Associates Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PAI Holdings, LLC. dba Pharmaceutical Associates Inc · 1700 Perimeter Rd · Greenville, SC · 29605-5252
Is this the product you have?
- Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only
- Mfg forPharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40
- Lot codes and dates
- Lots
C1EE Exp. 04/2021BD82 Exp. 11/2020BD83 Exp. 11/2020C16D Exp. 02/2021C563 Exp. 11/2021C574 Exp. 11/2021
- Lots
- Amount recalled
- 13480 cups
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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