JANUARY 2008
WEEK ENDING JANUARY 5
PRODUCT Baclofen Tablets
USP, 10 mg, 100 (10X10) unit dose tablets per package, Rx
only, NDC 68084-038-01,
CODE Lot
063789, exp. 11/30/07
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services Corp,
Columbus, OH, Manufacturer: Watson
Laboratories, Inc., Corona, CA.
REASON Product may not meet dissolution
specification over shelf life.
VOLUME OF PRODUCT IN
COMMERCE 1,501/100-tablet
packages
DISTRIBUTION Nationwide
WEEK ENDING JANUARY 12
PRODUCT Theophyline Extended-Release Capsules
USP, 200 mg, 100-capsule bottle, Rx
only, NDC-0258-3634-01 and 0456-4302-01, CODE Lot #: 6D005, exp.
2/12/08
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Forest Laboratories, Inc., Commack, NY,
Manufacturer: Inwood Labs,
Inwood, NY.
REASON Product does not meet specifications for
dissolution.
VOLUME OF PRODUCT IN COMMERCE 37,341
units
DISTRIBUTION Nationwide
WEEK ENDING JANUARY 19
PRODUCT Primidone Tablets,
USP, 50 mg, 100-tablet bottles, Rx Only, NDC
0603-5371-21,
CODE Lot T055A07A, exp.
01/09
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals
LLC, Huntsville, AL
REASON Product failed potency specification at
3-month stability test point.
VOLUME OF PRODUCT IN
COMMERCE 16,606
bottles
DISTRIBUTION Nationwide