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Recall Observatory FDA recall evidence

Drug product

Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma

D-1374-2019

May 21, 2019

Class II

Product summary

Firm
Torrent Pharma Inc
Event
Event 82889
Status
Terminated
Classification
Class II
Quantity
5,681 bottles
Official record key
drug-enforcement:D-1374-2019

Official wording

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

Code information: Lot #s: 17E001, Exp. 05/2019; 17F014, Exp. 06/2019; 17G005; 17G010, Exp. 07/2019; 17J019; 17J021, Exp. 09/2019; 17M008; 17M009, Exp. 12/2019.

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