Medications & Supplements/Prescription Drugs

Coastal Meds, LLC.: Various Injectable Medications Recalled for Unknown Particulate Matter

Agency Publication Date: May 9, 2018

Summary

Coastal Meds, LLC. is recalling 26,167 vials of various injectable medications, including Cyanocobalamin (Vitamin B12) and Lipo-B, due to the presence of unknown particulate matter. The presence of particles in an injectable drug can lead to serious health issues, such as inflammation or damage to blood vessels and organs. These products were distributed nationwide in 30 mL multi-dose vials between late 2017 and early 2018. Consumers should immediately stop using these products and contact their healthcare provider for guidance on alternative treatments and health concerns.

Risk

Injecting a medication containing unknown solid particles can cause blockages in blood vessels, leading to inflammation, granulomas in the lungs, or more severe systemic complications depending on where the particles travel in the body.

What You Should Do

Check your medication vials for the following product names: Cyanocobalamin, Adeno-Plex, Hydroxocobalamin, Lipo-B, Lipo-Den, Lipo-Den Extreme, Lipo-Den Plus, Lipo-Plex, Methylcobalamin, or Pyridoxine.
Verify the lot numbers and 'Discard by' dates on your 30 mL multi-dose vials (MDV). Affected lots include: C/010218 (Exp 7/1/18), AP/011218 (Exp 7/11/18), LB/120717 (Exp 6/5/18), LP/021618 (Exp 8/15/18), and many others listed in the product details.
Immediately stop using any injectable medication identified as part of this recall.
Contact your healthcare provider or pharmacist for guidance regarding alternative treatments and to report any adverse health effects.
Return any unused vials to the place of purchase for a refund and contact Coastal Meds, LLC. at their Biloxi, MS location for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: CYANOCOBALAMIN Injectable (30 mL MDV)

Model:

Recall #: D-0717-2018

Lot Numbers:

C/010218 (Exp 07/01/2018)

CAC/013118 (Exp 4/1/2018)

CAC/020518 (Exp 4/6/2018)

CAC/021418 (Exp 4/15/2018)

Product: ADENO-PLEX Injectable (30 mL MDV)

Model:

Recall #: D-0718-2018

Lot Numbers:

AP/011218 (Exp 7/11/2018)

Product: HYDROXOCOBALAMIN Injectable (30 mL MDV)

Model:

Recall #: D-0719-2018

Lot Numbers:

CAH/101617 (Exp 04/14/2018)

H/120117 (Exp 5/30/2018)

H/010518 (Exp 7/4/2018)

H/020718 (Exp 8/6/2018)

H/021518 (Exp 8/14/2018)

CAH/021218 (Exp 4/13/2018)

Product: LIPO-B Injectable (30 mL MDV)

Model:

Recall #: D-0720-2018

Lot Numbers:

LB/100517 (Exp 4/3/2018)

LB/111717 (Exp 5/16/2018)

LB/120717 (Exp 6/5/2018)

LB/010418 (Exp 7/3/2018)

LB/012618 (Exp 7/25/2018)

LB/022118 (Exp 8/20/2018)

CALB/012918 (Exp 3/30/2018)

CALB/021218 (Exp 4/13/2018)

Product: LIPO-DEN Injectable (30 mL MDV)

Model:

Recall #: D-0721-2018

Lot Numbers:

LD/120417 (Exp 6/2/2018)

LD/122017 (Exp 6/18/2018)

LD/011618 (Exp 7/15/2018)

CALD/013118 (Exp 4/1/2018)

CALD/020518 (Exp 4/6/2018)

CALD/021418 (Exp 4/15/2018)

Product: LIPO-DEN EXTREME Injectable (30 mL MDV)

Model:

Recall #: D-0722-2018

Lot Numbers:

LE/101917 (Exp 4/17/2018)

LE/110317 (Exp 5/2/2018)

LE/110917 (Exp 5/8/2018)

LE/010318 (Exp 7/2/2018)

LE/012218 (Exp 7/21/2018)

LE/020918 (Exp 8/8/2017)

Product: LIPO-DEN PLUS Injectable (30 mL MDV)

Model:

Recall #: D-0723-2018

Lot Numbers:

LDP/100317 (Exp 4/1/2018)

LDP/011618 (Exp 7/15/2018)

CALDP/020118 (Exp 7/31/2018)

CALDP/012918 (Exp 3/30/2018)

CALDP/021518 (Exp 4/16/2018)

Product: LIPO-PLEX Injectable (30 mL MDV)

Model:

Recall #: D-0724-2018

Lot Numbers:

LP/100617 (Exp 4/4/2018)

LP/101817 (Exp 4/16/2018)

LP/103117 (Exp 4/29/2018)

LP/110817 (Exp 5/7/2018)

LP/111617 (Exp 5/15/2018)

LP/120617 (Exp 6/4/2018)

LP/120817 (Exp 6/6/2018)

LP/121417 (Exp 6/12/2018)

LP/010918 (Exp 7/8/2018)

LP/011818 (Exp 07/17/2018)

LP/012518 (Exp 7/24/2018)

LP/020818 (Exp 8/7/2018)

LP/021618 (Exp 8/15/2018)

CALP/021218 (Exp 4/13/2018)

Product: METHYLCOBALAMIN Injectable (30 mL MDV)

Model:

Recall #: D-0725-2018

Lot Numbers:

MC/102017 (Exp 4/18/2018)

MC/110217 (Exp 5/1/2018)

MC/120517 (Exp 6/3/2018)

MC/122117 (Exp 6/19/2018)

MC011718 (Exp 7/16/2018)

MC/012418 (Exp 7/23/2018)

MC/022018 (Exp 8/19/2018)

MC/021518 (Exp 4/16/2018)

CAMC/013018 (Exp 3/31/2018)

Product: PYRIDOXINE Injectable (30 mL MDV)

Model:

Recall #: D-0726-2018

Lot Numbers:

P/121517 (Exp 6/13/2018)

CAP/013118 (Exp 4/1/2018)

CAP/020518 (Exp 4/6/2018)

CAP/021418 (Exp 4/15/2018)

CAP/021918 (Exp 4/20/2018)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79671

Status: Resolved

Manufacturer: Coastal Meds, LLC.

Sold By: Direct from Coastal Meds, LLC.

Manufactured In: United States

Units Affected: 10 products (745 vials; 200 vials; 1506 vials; 3959 vials; 1309 vials; 3733 vials; 1457 vials; 8099 vials; 4524 vials; 635 vials)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication vials for the following product names: Cyanocobalamin, Adeno-Plex, Hydroxocobalamin, Lipo-B, Lipo-Den, Lipo-Den Extreme, Lipo-Den Plus, Lipo-Plex, Methylcobalamin, or Pyridoxine.

Verify the lot numbers and 'Discard by' dates on your 30 mL multi-dose vials (MDV). Affected lots include: C/010218 (Exp 7/1/18), AP/011218 (Exp 7/11/18), LB/120717 (Exp 6/5/18), LP/021618 (Exp 8/15/18), and many others listed in the product details.

Immediately stop using any injectable medication identified as part of this recall.

Contact your healthcare provider or pharmacist for guidance regarding alternative treatments and to report any adverse health effects.

Return any unused vials to the place of purchase for a refund and contact Coastal Meds, LLC. at their Biloxi, MS location for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: CYANOCOBALAMIN Injectable (30 mL MDV)

Model:

Recall #: D-0717-2018

Lot Numbers:

C/010218 (Exp 07/01/2018)

CAC/013118 (Exp 4/1/2018)

CAC/020518 (Exp 4/6/2018)

CAC/021418 (Exp 4/15/2018)

Product: ADENO-PLEX Injectable (30 mL MDV)

Model:

Recall #: D-0718-2018

Lot Numbers:

AP/011218 (Exp 7/11/2018)

Product: HYDROXOCOBALAMIN Injectable (30 mL MDV)

Model:

Recall #: D-0719-2018

Lot Numbers:

CAH/101617 (Exp 04/14/2018)

H/120117 (Exp 5/30/2018)

H/010518 (Exp 7/4/2018)

H/020718 (Exp 8/6/2018)

H/021518 (Exp 8/14/2018)

CAH/021218 (Exp 4/13/2018)

Product: LIPO-B Injectable (30 mL MDV)

Model:

Recall #: D-0720-2018

Lot Numbers:

LB/100517 (Exp 4/3/2018)

LB/111717 (Exp 5/16/2018)

LB/120717 (Exp 6/5/2018)

LB/010418 (Exp 7/3/2018)

LB/012618 (Exp 7/25/2018)

LB/022118 (Exp 8/20/2018)

CALB/012918 (Exp 3/30/2018)

CALB/021218 (Exp 4/13/2018)

Product: LIPO-DEN Injectable (30 mL MDV)

Model:

Recall #: D-0721-2018

Lot Numbers:

LD/120417 (Exp 6/2/2018)

LD/122017 (Exp 6/18/2018)

LD/011618 (Exp 7/15/2018)

CALD/013118 (Exp 4/1/2018)

CALD/020518 (Exp 4/6/2018)

CALD/021418 (Exp 4/15/2018)

Product: LIPO-DEN EXTREME Injectable (30 mL MDV)

Model:

Recall #: D-0722-2018

Lot Numbers:

LE/101917 (Exp 4/17/2018)

LE/110317 (Exp 5/2/2018)

LE/110917 (Exp 5/8/2018)

LE/010318 (Exp 7/2/2018)

LE/012218 (Exp 7/21/2018)

LE/020918 (Exp 8/8/2017)

Product: LIPO-DEN PLUS Injectable (30 mL MDV)

Model:

Recall #: D-0723-2018

Lot Numbers:

LDP/100317 (Exp 4/1/2018)

LDP/011618 (Exp 7/15/2018)

CALDP/020118 (Exp 7/31/2018)

CALDP/012918 (Exp 3/30/2018)

CALDP/021518 (Exp 4/16/2018)

Product: LIPO-PLEX Injectable (30 mL MDV)

Model:

Recall #: D-0724-2018

Lot Numbers:

LP/100617 (Exp 4/4/2018)

LP/101817 (Exp 4/16/2018)

LP/103117 (Exp 4/29/2018)

LP/110817 (Exp 5/7/2018)

LP/111617 (Exp 5/15/2018)

LP/120617 (Exp 6/4/2018)

LP/120817 (Exp 6/6/2018)

LP/121417 (Exp 6/12/2018)

LP/010918 (Exp 7/8/2018)

LP/011818 (Exp 07/17/2018)

LP/012518 (Exp 7/24/2018)

LP/020818 (Exp 8/7/2018)

LP/021618 (Exp 8/15/2018)

CALP/021218 (Exp 4/13/2018)

Product: METHYLCOBALAMIN Injectable (30 mL MDV)

Model:

Recall #: D-0725-2018

Lot Numbers:

MC/102017 (Exp 4/18/2018)

MC/110217 (Exp 5/1/2018)

MC/120517 (Exp 6/3/2018)

MC/122117 (Exp 6/19/2018)

MC011718 (Exp 7/16/2018)

MC/012418 (Exp 7/23/2018)

MC/022018 (Exp 8/19/2018)

MC/021518 (Exp 4/16/2018)

CAMC/013018 (Exp 3/31/2018)

Product: PYRIDOXINE Injectable (30 mL MDV)

Model:

Recall #: D-0726-2018

Lot Numbers:

P/121517 (Exp 6/13/2018)

CAP/013118 (Exp 4/1/2018)

CAP/020518 (Exp 4/6/2018)

CAP/021418 (Exp 4/15/2018)

CAP/021918 (Exp 4/20/2018)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79671

Status: Resolved

Manufacturer: Coastal Meds, LLC.

Sold By: Direct from Coastal Meds, LLC.

Manufactured In: United States

Units Affected: 10 products (745 vials; 200 vials; 1506 vials; 3959 vials; 1309 vials; 3733 vials; 1457 vials; 8099 vials; 4524 vials; 635 vials)

Distributed To: Nationwide