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04-14-2009, 11:57 AM
FDA class III recall:
PRODUCT
Ultram ER (tramadol HCL) Extended-Release Tablets, 100 mg, 30 tablets, HPDE bottle, Rx only, NDC 0062-0653-30, Recall # D-169-2009
CODE
Lot/Expiration: P07L026, Exp. 9/2009; P07L027, Exp. 9/2009; P08A039, Exp 9/2009; P08B043, Exp. 9/2009; P08A040, Exp. 10/2009; P08A041, Exp. 10/2009; P08A042, Exp. 10/2009; P08C040, Exp. 11/2009; P08E024, Exp. 11/2009; P08E025, Exp. 11/2009; P08E026, Exp. 11/2009; 08D010P, Exp. 1/2010; 08D012P, Exp. 1/2010; P08E055, Exp. 1/2010; P08E056, Exp. 1/2010; P08F025, Exp. 1/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-McNeil Pharmaceutical, Inc. Raritan, NJ, by letters on December 30, 2008 and January 5, 2009.
Manufacturer: Biovail Corp., Manitoba, Canada. Firm initiated recall is ongoing.
REASON
Specific lot numbers may release the active ingredient at a slightly faster rate than required by the products release rate specification at the 8-hour time point
VOLUME OF PRODUCT IN COMMERCE
271,920 bottles
DISTRIBUTION
Nationwide
PRODUCT
Ultram ER (tramadol HCL) Extended-Release Tablets, 100 mg, 30 tablets, HPDE bottle, Rx only, NDC 0062-0653-30, Recall # D-169-2009
CODE
Lot/Expiration: P07L026, Exp. 9/2009; P07L027, Exp. 9/2009; P08A039, Exp 9/2009; P08B043, Exp. 9/2009; P08A040, Exp. 10/2009; P08A041, Exp. 10/2009; P08A042, Exp. 10/2009; P08C040, Exp. 11/2009; P08E024, Exp. 11/2009; P08E025, Exp. 11/2009; P08E026, Exp. 11/2009; 08D010P, Exp. 1/2010; 08D012P, Exp. 1/2010; P08E055, Exp. 1/2010; P08E056, Exp. 1/2010; P08F025, Exp. 1/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-McNeil Pharmaceutical, Inc. Raritan, NJ, by letters on December 30, 2008 and January 5, 2009.
Manufacturer: Biovail Corp., Manitoba, Canada. Firm initiated recall is ongoing.
REASON
Specific lot numbers may release the active ingredient at a slightly faster rate than required by the products release rate specification at the 8-hour time point
VOLUME OF PRODUCT IN COMMERCE
271,920 bottles
DISTRIBUTION
Nationwide