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Class II: temporary or reversible health riskTerminated

Coastal Meds LIPO-DEN Injectable-30 mL MDV Coastal Meds Recall

LIPO-DEN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr

Coastal Meds, LLC. · Biloxi, MS

Risk level
Class II
Reported by FDA
May 2, 2018
Recall ID
D-0721-2018
Check your lot numberHow we source this data

Summary

Coastal Meds recalled LIPO-DEN Injectable-30 mL MDV Coastal Meds starting Apr 5, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0721-2018 on May 2, 2018. Reason: Presence of Particulate matter. Recall due to presence of unknown particulate matter. Status: Terminated.

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

Lots: LD/120417 Discard by 6/2/2018; LD/122017 Discard by 6/18/2018; LD/011618 Discard by 7/15/2018; CALD/013118 Discard by 4/1/2018; CALD/020518 Discard by 4/6/2018; CALD/021418 Discard by 4/15/2018

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-0721-2018
Classification
Class II
Status
Terminated
Recall initiated
Apr 5, 2018
FDA report date
May 2, 2018
Quantity
1309 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Coastal Meds, LLC.

Original FDA data

Every field from FDA enforcement report D-0721-2018, 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
Lots: LD/120417 Discard by 6/2/2018; LD/122017 Discard by 6/18/2018; LD/011618 Discard by 7/15/2018; CALD/013118 Discard by 4/1/2018; CALD/020518 Discard by 4/6/2018; CALD/021418 Discard by 4/15/2018
Postal code
39532-2154
Report date
May 2, 2018
Product type
Drugs
Recall number
D-0721-2018
Classification
Class II
Recalling firm
Coastal Meds, LLC.
Product quantity
1309 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
LIPO-DEN 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
E-Mail
Center classification date
May 9, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0721-2018, published May 2, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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