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Recall Observatory FDA recall evidence

Drug 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..

D-1381-2019

May 21, 2019

Class II

Product summary

Firm
Torrent Pharma Inc
Event
Event 82889
Status
Terminated
Classification
Class II
Quantity
730,476 bottles
Official record key
drug-enforcement:D-1381-2019

Official wording

Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information: 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; 19A003; 19A022, Exp. 01/2021; 19B009, Exp. 02/2021.

Distribution pattern: Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations
  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    contamination with Burkholderia cepacia (B.cepacia) and Ralstonia