FDA Recall D-0219-2017
US Compounding Inc · Conway, AR
Class I — life-threatening Terminated 255 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
Recall record
- Recall number
D-0219-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- TX
- Recall initiated
- 2016-07-25
- Classified by FDA Center
- 2016-12-22
- FDA published
- 2016-12-28
- Terminated
- 2017-04-06
- Recalling firm
- US Compounding Inc
- Firm location
- Conway, AR