Why it was recalled
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Product description
ADENO-PLEX Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Lot numbers, UPCs & expiration codes
Lot: AP/011218 Discard by 7/11/2018
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0718-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 5, 2018
- FDA report date
- May 2, 2018
- Quantity
- 200 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Coastal Meds, LLC.
Original FDA data
Every field from FDA enforcement report D-0718-2018, exactly as published.
Show all FDA fields
- City
- Biloxi
- State
- MS
- Status
- Terminated
- Country
- United States
- Event ID
- 79671
- Address
- 1759 Medical Park Dr Ste C
- Code information
- Lot: AP/011218 Discard by 7/11/2018
- Postal code
- 39532-2154
- Report date
- May 2, 2018
- Product type
- Drugs
- Recall number
- D-0718-2018
- Classification
- Class II
- Recalling firm
- Coastal Meds, LLC.
- Product quantity
- 200 vials
- Termination date
- Nov 24, 2020
- Reason for recall
- Presence of Particulate matter. Recall due to presence of unknown particulate matter.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ADENO-PLEX Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 5, 2018
- Initial firm notification
- Center classification date
- May 9, 2018