notyard
04-14-2009, 02:15 PM
FDA class II recall:
PRODUCT
APS Ursodiol Capsules USP 300 mg, NDC 51079-097-20 Dose NCD 51079-097-01. Recall # D-181-2009
CODE
Lot #072890 Exp Date 11/08; Lot #073356 Exp Date 11/08; Lot #073995 Exp Date 02/09; Lot #074202 Exp Date 02/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus , OH , by letters on August 6, 2008.
Manufacturer: Actavis Totowa LLC, Totowa , NJ . Firm initiated recall is ongoing.
REASON
GMP Deviations (by mfr Actavis)
VOLUME OF PRODUCT IN COMMERCE
184 amber bags of 100 capsules
DISTRIBUTION
GA, PA and TX
PRODUCT
APS Ursodiol Capsules USP 300 mg, NDC 51079-097-20 Dose NCD 51079-097-01. Recall # D-181-2009
CODE
Lot #072890 Exp Date 11/08; Lot #073356 Exp Date 11/08; Lot #073995 Exp Date 02/09; Lot #074202 Exp Date 02/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus , OH , by letters on August 6, 2008.
Manufacturer: Actavis Totowa LLC, Totowa , NJ . Firm initiated recall is ongoing.
REASON
GMP Deviations (by mfr Actavis)
VOLUME OF PRODUCT IN COMMERCE
184 amber bags of 100 capsules
DISTRIBUTION
GA, PA and TX