Recalls / Class I
Class ID-0022-2017
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
Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85
- Affected lot / code info
- 20351407, 20351408, exp 09/16; 20351409, exp 11/16; 20351410, exp 12/16; 20351501, 20351502, exp 01/17; 20351503, exp 03/17; 20351504, exp 04/17; 20351505, exp 05/17; 20351506, 20351507, exp 06/17; 20351508, exp 07/17, 20351509, 20351510, exp 10/17; 20351511, 20351512, 20351513, exp 11/17; 20351601, exp 01/18; 20351602, exp 02/18; 20351603, exp 03/18; 20351604, 20351605, exp 04/18
Why it was recalled
Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
Recalling firm
- Firm
- The Harvard Drug Group
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 31778 Enterprise Dr, N/A, Livonia, Michigan 48150-1960
Distribution
- Quantity
- 153,432 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-07-15
- FDA classified
- 2016-10-12
- Posted by FDA
- 2016-10-19
- Terminated
- 2017-03-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0022-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.