Drug product

Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL OZ (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street, Brooklyn, NY 11204, NDC 57896-403-16, UPC 357896-403164,

D-0852-2018

May 07, 2018

Class II

Product summary

Reason: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

Code information: Lot #: 47080041, 47080051, Exp. 08/19

Distribution pattern: Nationwide in the USA

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations
Potency or specification failure
reason.potency_specification_failure · v1.0.0

out of specification