Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma
Reported: June 19, 2019 Initiated: May 21, 2019 #D-1374-2019
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).
Details
- Recalling Firm
- Torrent Pharma Inc
- Units Affected
- 5,681 bottles
- Distribution
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
- Location
- Levittown, PA
Frequently Asked Questions
What product was recalled? ▼
Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma. Recalled by Torrent Pharma Inc. Units affected: 5,681 bottles.
Why was this product recalled? ▼
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 19, 2019. Severity: Moderate. Recall number: D-1374-2019.
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