Torrent Pharma Recalls Cetirizine Hydrochloride Oral Solution Due to Contamination
Torrent Pharma Inc. is recalling specific lots of Cetirizine Hydrochloride Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with hospitalization reports or significant injury/property-damage reports are Severe. While specific injury reports are not detailed in the provided text, the presence of bacterial contamination in an oral solution warrants a high severity rating consistent with Class II classifications involving potential harm.
Plain-English summary
Torrent Pharma Inc. is recalling 730,476 bottles of Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, 120 mL bottles. The recall involves specific lots of NDC 13668-029-07 and NDC 13668-596-07 manufactured by Bio-Pharm, Inc. for Torrent Pharma Inc.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations that resulted in potential product contamination with Burkholderia cepacia and Ralstonia pickettii. The affected product was distributed to 9 distributors, direct accounts, and relabelers, who may have further distributed the product throughout the United States.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the distributor or pharmacy of purchase for a refund or replacement.
The recalled product
- Product
- Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL bottle, a) NDC 13668-029-07, b) NDC 13668-596-07, Manufactured by Bio-Pharm, Inc. Levittown, PA, For Torrent Pharma Inc., Basking Ridge, NJ 07920..
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 730,476
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 (20)
- Lot #s: a) Lot #: 18D027
- 18D028
- 18D029
- Exp. 04/2020. b) 18D029A
- Exp. 04/2020
- 18E001B
- 18E010B
- Exp. 05/2020
- 18F016A
- 18F017A
- 18F037A
- Exp. 06/2020
- 18J021
- 18J023
- 18J023A
- 18J024
- Exp. 09/2020
- 18K001
- 18K002
- Exp. 10/2020
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 41 recalled by Torrent Pharma Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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