Recalls / Class II
Class IID-0719-2018
Product
HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
- Affected lot / code info
- Lots: CAH/101617 Discard by 04/14/2018; H/120117 Discard by 5/30/2018; H/010518 Discard by 7/4/2018; H/020718 Discard by 8/6/2018; H/021518 Discard by 8/14/2018 ; CAH/021218 Discard by 4/13/2018
Why it was recalled
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Recalling firm
- Firm
- Coastal Meds, LLC.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1759 Medical Park Dr Ste C, N/A, Biloxi, Mississippi 39532-2154
Distribution
- Quantity
- 1506 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-0719-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.