Pharmaceutical Associates Recalls Citalopram Oral Solution Due to Impurities
Pharmaceutical Associates Inc. is recalling Citalopram Oral Solution due to high impurity levels found during stability testing.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition indicates that use of the product is not likely to cause adverse health consequences, aligning with the 'Low' severity criterion for documentation or minor specification issues without reported harm.
Plain-English summary
Pharmaceutical Associates Inc. is recalling Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups. The recall involves 13,480 cups distributed nationwide. The product is prescription-only and was manufactured for Pharmaceutical Associates, Inc. in Greenville, SC.
The recall was initiated because the product failed impurities and degradation specifications. Specifically, high out-of-specification results were obtained at the 9-month stability timepoint. The affected lots are C1EE (Exp. 04/2021), BD82 (Exp. 11/2020), BD83 (Exp. 11/2020), C16D (Exp. 02/2021), C563 (Exp. 11/2021), and C574 (Exp. 11/2021).
The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should discontinue use of the affected lots and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- 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
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 13,480
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distribution
Distributed nationwide across the United States.
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