Multi-event August 2013 FDA Recall Drug by South Coast Specialty Compounding, Inc.

This Multi-event Class II drug recall was voluntarily initiated by South Coast Specialty Compounding, Inc. on August 23, 2013 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in CA, IN and the recall is currently terminated.

Reported Recall Events

D-1027-2013 TERMINATED D-1026-2013 TERMINATED D-1025-2013 TERMINATED

Recall Number: D-1027-2013

Reason for Recall
Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcobalamin 5mg/ml and Multitrace-5 Concentrate, and one lot of Testosterone Cypionate (sesame oil) for injection due lack of sterility assurance.
Initiated
08-23-2013
Reported
09-18-2013
Quantity
117 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66083
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
South Coast Specialty Compounding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA, IN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-17-2013
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA

Batch or Lot Expiration Information

Lot# 05072013@1, Exp 11/3/2013

Recall Number: D-1026-2013

Reason for Recall
Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance.
Initiated
08-23-2013
Reported
09-18-2013
Quantity
82 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66083
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
South Coast Specialty Compounding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA, IN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-17-2013
Product Description About Product Description
Full technical description of the product.
Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL Multiple Dose Vial, For Slow IV Administration After Dilution Only, Park Compounding, Irvine, CA

Batch or Lot Expiration Information

Lot# 05212013@20 and
Lot# 03212013@6, Exp 11/17/2013

Recall Number: D-1025-2013

Reason for Recall
Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance.
Initiated
08-23-2013
Reported
09-18-2013
Quantity
297 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66083
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
South Coast Specialty Compounding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA, IN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-17-2013
Product Description About Product Description
Full technical description of the product.
Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA

Batch or Lot Expiration Information

Lot# 06132013@1, Exp 12/10/2013