Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical...

FDA Drug Recall #D-0015-2021 — Class III — September 9, 2020

Recall Summary

Recall Number D-0015-2021
Classification Class III — Low risk
Date Initiated September 9, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Location Greenville, SC
Product Type Drugs
Quantity 13480 cups

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

Reason for Recall

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

Distribution Pattern

Nationwide.

Lot / 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

Other Recalls from PAI Holdings, LLC. dba Pharmaceutical...

Recall # Classification Product Date
D-0222-2025 Class III Guaifenesin and Codeine Phosphate Oral Solution... Jan 7, 2025
D-0723-2021 Class II Ethosuximide Oral Solution USP 250 mg/5 mL, 16 ... Jul 29, 2021
D-0722-2021 Class II Cimetidine Hydrochloride Oral Solution 300 mg/5... Jul 29, 2021
D-0721-2021 Class II Nystatin Oral Suspension, USP 100,000 units per... Jul 29, 2021
D-1494-2020 Class II Nystatin Oral Suspension, USP 100,000 units per... Aug 4, 2020

Frequently Asked Questions

Nitrosamines are probable human carcinogens — they can increase cancer risk with long-term exposure above certain thresholds, but they do not cause immediate harm from taking a single dose. The FDA calculates an acceptable daily intake (ADI) for each nitrosamine compound, and recalls are triggered when levels exceed this threshold. If you have been taking a recalled product, the FDA generally advises against abruptly stopping your medication (especially for critical conditions like blood pressure or diabetes) until you consult your doctor. The incremental cancer risk from short-term exposure is very small.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.