Multi-event April 2018 FDA Recall Drug by Coastal Meds, Llc.
This Multi-event Class II drug recall was voluntarily initiated by Coastal Meds, Llc. on April 5, 2018 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. recall due to presence of unknown particulate matter.. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
D-0721-2018 D-0725-2018 D-0719-2018 D-0724-2018 D-0718-2018 D-0720-2018 D-0717-2018 D-0722-2018 D-0723-2018 D-0726-2018
Recall Number: D-0721-2018
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
04-05-2018
05-02-2018
1309 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Coastal Meds, LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
11-24-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
LIPO-DEN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Batch or Lot Expiration Information
Lot# 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
Recall Number: D-0725-2018
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
04-05-2018
05-02-2018
4524 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Coastal Meds, LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
11-24-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
METHYLCOBALAMIN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Batch or Lot Expiration Information
Lot# Lots: MC/102017 Discard by 4/18/2018; MC/110217 Discard by 5/1/2018; MC/120517 Discard by 6/3/2018; MC/122117 Discard by 6/19/2018; MC011718 Discard by 7/16/2018; MC/012418 Discard by 7/23/2018; MC/022018 Discard by 8/19/2018; MC/021518 Discard by 4/16/2018; CAMC/013018 Discard by 3/31/2018
Recall Number: D-0719-2018
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
04-05-2018
05-02-2018
1506 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Coastal Meds, LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
11-24-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Batch or Lot Expiration Information
Lot# 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
Recall Number: D-0724-2018
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
04-05-2018
05-02-2018
8099 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Coastal Meds, LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
11-24-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
LIPO-PLEX Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Batch or Lot Expiration Information
Lot# Lots: LP/100617 Discard by 4/4/2018; LP/101817 Discard by 4/16/2018; LP/103117 Discard by 4/29/2018; LP/110817 Discard by 5/7/2018; LP/111617 Discard by 5/15/2018; LP/120617 Discard by 6/4/2018; LP/120817 Discard by 6/6/2018; LP/121417 Discard by 6/12/2018; LP/010918 Discard by 7/8/2018; LP/011818 Discard by 07/17/2018; LP/012518 Discard by 7/24/2018; LP/020818 Discard by 8/7/2018; LP/021618 Discard by 8/15/2018; CALP/021218 Discard by 4/13/2018
Recall Number: D-0718-2018
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
04-05-2018
05-02-2018
200 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Coastal Meds, LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
11-24-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ADENO-PLEX Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Batch or Lot Expiration Information
Lot# Lot: AP/011218 Discard by 7/11/2018
Recall Number: D-0720-2018
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
04-05-2018
05-02-2018
3959 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Coastal Meds, LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
11-24-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
LIPO-B Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Batch or Lot Expiration Information
Lot# Lots: LB/100517 Discard by 4/3/2018; LB/111717 Discard by 5/16/2018; LB/120717 Discard by 6/5/2018; LB/010418 Discard by 7/3/2018; LB/012618 Discard by 7/25/2018; LB/022118 Discard by 8/20/2018; CALB/012918 Discard by 3/30/2018; CALB/021218 Discard by 4/13/2018
Recall Number: D-0717-2018
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
04-05-2018
05-02-2018
745 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Coastal Meds, LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
11-24-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Batch or Lot Expiration Information
Lot# Lot: C/010218 Discard by 07/01/2018; CAC/013118 Discard by 4/1/2018; CAC/020518 Discard by 4/6/2018; CAC/021418 Discard by 4/15/2018
Recall Number: D-0722-2018
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
04-05-2018
05-02-2018
3733 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Coastal Meds, LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
11-24-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
LIPO-DEN EXTREME Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Batch or Lot Expiration Information
Lot# Lots: LE/101917 Discard by 4/17/2018; LE/110317 Discard by 5/2/2018; LE/110917 Discard by 5/8/2018; LE/010318 Discard by 7/2/2018; LE/012218 Discard by 7/21/2018; LE/020918 Discard by 8/8/2017
Recall Number: D-0723-2018
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
04-05-2018
05-02-2018
1457 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Coastal Meds, LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
11-24-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
LIPO-DEN PLUS Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Batch or Lot Expiration Information
Lot# Lots: LDP/100317 Discard by 4/1/2018; LDP/011618 Discard by 7/15/2018; CALDP/020118 Discard by 7/31/2018; CALDP/012918 Discard by 3/30/2018; CALDP/021518 Discard by 4/16/2018
Recall Number: D-0726-2018
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
04-05-2018
05-02-2018
635 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Coastal Meds, LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
11-24-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PYRIDOXINE Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Batch or Lot Expiration Information
Lot# 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
