Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1001-85.
Reported: October 5, 2016 Initiated: August 8, 2016 #D-1524-2016
Product Description
Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1001-85.
Reason for Recall
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Details
- Recalling Firm
- Pharmatech LLC
- Units Affected
- 19,656 bottles
- Distribution
- Nationwide
- Location
- Davie, FL
Frequently Asked Questions
What product was recalled? ▼
Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1001-85.. Recalled by Pharmatech LLC. Units affected: 19,656 bottles.
Why was this product recalled? ▼
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 5, 2016. Severity: Moderate. Recall number: D-1524-2016.
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