Why it was recalled
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0015-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 9, 2020
- FDA report date
- Oct 14, 2020
- Quantity
- 13480 cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Original FDA data
Every field from FDA enforcement report D-0015-2021, exactly as published.
Show all FDA fields
- City
- Greenville
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 86409
- Address
- 1700 Perimeter Rd
- Code information
- 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
- Postal code
- 29605-5252
- Report date
- Oct 14, 2020
- Product type
- Drugs
- Recall number
- D-0015-2021
- Classification
- Class III
- Recalling firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Product quantity
- 13480 cups
- Termination date
- Feb 22, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide.
- Recall initiation date
- Sep 9, 2020
- Initial firm notification
- Letter
- Center classification date
- Oct 5, 2020