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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