The FDA has released the following information.
PRODUCT
Dakin's Solution 0.25% By Century Half Strength, (0.25%
sodium hypochlorite), 473 mL 16 Fl. OZ. Recall # D-122-4.
CODE
Lot Number: 871/Expiration Date: 10/27/2004.
RECALLING FIRM/MANUFACTURER
Century Pharmaceuticals, Inc, Indianapolis, IN, by letter and fax on January 15, and January 23, 2004. Firm initiated recall is ongoing.
REASON
Subpotent: Stability assay failed to meet specification limits.
VOLUME OF PRODUCT IN COMMERCE
1,200.
DISTRIBUTION
Nationwide.
PRODUCT
Dakin's Solution 0.25% By Century Half Strength, (0.25%
sodium hypochlorite), 473 mL 16 Fl. OZ. Recall # D-122-4.
CODE
Lot Number: 871/Expiration Date: 10/27/2004.
RECALLING FIRM/MANUFACTURER
Century Pharmaceuticals, Inc, Indianapolis, IN, by letter and fax on January 15, and January 23, 2004. Firm initiated recall is ongoing.
REASON
Subpotent: Stability assay failed to meet specification limits.
VOLUME OF PRODUCT IN COMMERCE
1,200.
DISTRIBUTION
Nationwide.
