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Terminated

remel THIOGLYCOLLATE MEDIUM, REF 05152

FDA Recall Z-3019-2018 · Posted None

Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeJSG
Date Initiated2018-08-13
Date Terminated2019-06-18
Product Quantity48 units

Reason for Recall

Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.

Firm Action

The firm initiated the recall by letter on 08/13/2018. The firm directed the consignee to you inspect their stock and destroy any remaining inventory of the lots listed above and contact Customer Services or your local distributor regarding replacement. They also requested that the consignee review results and laboratory reporting associated with use of the listed lots and consider retesting and/or seek appropriate expert advice for further action. The firm instructed the consignee to further distribute the notice to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. For questions, please contact Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).

Root Cause

Under Investigation by firm

Distribution Pattern

US, Canada, Singapore

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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