July 2016 FDA Recall Drug by Us Compounding Inc
D-0219-2017 - Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
This Class I drug recall was voluntarily initiated by Us Compounding Inc on July 25, 2016 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products; microbial contamination with b. cepacia. The product was distributed in TX and the recall is currently terminated.
Recall Number: D-0219-2017
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
07-25-2016
12-28-2016
10,665 syringes
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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.
US Compounding Inc
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
TX
04-06-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR
Batch or Lot Expiration Information
Lot# All Lots
