FDA Drug Recalls

Recalls / Class II

Class IID-0726-2018

Product

PYRIDOXINE Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532

Affected lot / code info
Lots: P/121517 Discard by 6/13/2018; CAP/013118 Discard by 4/1/2018; CAP/020518 Discard by 4/6/2018; CAP/021418 Discard by 4/15/2018; CAP/021918 Discard by 4/20/2018

Why it was recalled

Presence of Particulate matter. Recall due to presence of unknown particulate matter.

Recalling firm

Firm
Coastal Meds, LLC.
Notification channel
E-Mail
Type
Voluntary: Firm initiated
Address
1759 Medical Park Dr Ste C, N/A, Biloxi, Mississippi 39532-2154

Distribution

Quantity
635 vials
Distribution pattern
Nationwide in the USA

Timeline

Recall initiated
2018-04-05
FDA classified
2018-05-09
Posted by FDA
2018-05-02
Terminated
2020-11-24
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0726-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.