D-1374-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 19, 2019
- Initiation Date
- May 21, 2019
- Termination Date
- October 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,681 bottles
Product Description
Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma
Reason for Recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Distribution Pattern
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
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.