RecallDepth

MicroBiologics; P. vulgaris, DuoPacksl Product Catalog Number: 0691P; ARCC 0427; Exp 2008-9; MicroBiologics, St. Cloud, MN 56303. (Proteus vulgaris, Kwik-Stick, Cat. No. 0691P)

This recall has been terminated (originally issued December 29, 2007).

Company
Microbiologics Inc
Recall Initiated
October 12, 2007
Posted
December 29, 2007
Terminated
June 26, 2008
Recall Number
Z-0456-2008
Quantity
20
Firm Location
Saint Cloud, MN
Official Source
View on FDA website ↗

Reason for Recall

Mislabeled: DuoPacks of Proteus vulgaris contained Listeria monocytogenes instead of the labeled Proteus vulgaris.

Distribution

Worldwide Distribution - USA including states of OR, PA, NY, RI, GA, SC, IL, PR, CA, AZ, and NJ, and countries of Japan, France, Colombia, and Brazil.

Lot / Code Info

Lot Number: 691295

Root Cause

Employee error

Action Taken

Consignees were initially notified of this recall by a telephone survey. An Urgent Product Recall letter was sent on 10/17/07 explaining the risk to patients. The firm sent replacements of the recalled product on 10/17/07 or 10/18/07, with request for acknowledgement of Recall Notification, and certification of disposal of incorrect product.

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