Reported Jun 19, 2019 · Terminated
Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL bottle, a) NDC 13668-029-07, b)…
Torrent Pharma Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Torrent Pharma Inc · 2091 Hartel Ave · Levittown, PA · 19057-4506
Is this the product you have?
- 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..
- Lot codes and dates
Lot #s: a) Lot #: 18D02718D02818D029Exp. 04/2020. b) 18D029AExp. 04/202018E001B18E010BExp. 05/202018F016A18F017A18F037AExp. 06/202018J02118J02318J023A18J024Exp. 09/202018K00118K002Exp. 10/202019A00319A022Exp. 01/202119B009Exp. 02/2021
- Amount recalled
- 730,476 bottles
This recall covers 41 products
The agency filed one notice per product. You are reading one of them; the other 40 are below.
28 more are in the archive.
Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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