Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD
Reported: June 19, 2019 Initiated: May 21, 2019 #D-1361-2019
Product Description
Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD
Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Details
- Recalling Firm
- Torrent Pharma Inc
- Units Affected
- 361,260 bottles
- Distribution
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
- Location
- Levittown, PA
Frequently Asked Questions
What product was recalled? ▼
Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD. Recalled by Torrent Pharma Inc. Units affected: 361,260 bottles.
Why was this product recalled? ▼
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 19, 2019. Severity: Moderate. Recall number: D-1361-2019.
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