Recalls / Class I
Class ID-0219-2017
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- All Lots
Why it was recalled
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
Recalling firm
- Firm
- US Compounding Inc
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1270 Don's Lane, N/A, Conway, Arkansas 72032
Distribution
- Quantity
- 10,665 syringes
- Distribution pattern
- TX
Timeline
- Recall initiated
- 2016-07-25
- FDA classified
- 2016-12-22
- Posted by FDA
- 2016-12-28
- Terminated
- 2017-04-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0219-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.