Drug product
Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma
D-1374-2019
Product summary
- 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
cGMP Deviations
-
Microbial contamination
contamination with Burkholderia cepacia (B.cepacia) and Ralstonia