Recalls / Class III
Class IIID-0015-2021
Product
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
- Affected lot / code info
- Lots: C1EE Exp. 04/2021, BD82 Exp. 11/2020, BD83 Exp. 11/2020, C16D Exp. 02/2021, C563 Exp. 11/2021, C574 Exp. 11/2021
Why it was recalled
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
Recalling firm
- Firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1700 Perimeter Rd, N/A, Greenville, South Carolina 29605-5252
Distribution
- Quantity
- 13480 cups
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2020-09-09
- FDA classified
- 2020-10-05
- Posted by FDA
- 2020-10-14
- Terminated
- 2022-02-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0015-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.