February 2012 Drug Update Information - Pharmacy Benefits ...

PRODUCT (CLASSS II)
1) LO/OVRAL-28 (norgestrel and ethinyl estradiol tablets), 21 white
tablets each
containing
0.3
mg norgestrel with 0.03 mg ethinyl estradiol, and 7 pink inert tablets, Package contains 6 Pilpak
Dispensers of 28 Tablets each, Rx Only, NDC 24090-801-84. Recalll # D-1188-2012;
2) Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg Tablets --- 21 white tablets, each
containing
0.3
mg norgestrel with 0.03 mg ethinyl estradiol, and 7 pink inert tablets, Package contains 6 Pilpak
Dispensers of 28 Tablets each, Rx Only, NDC 24090-961-84. Recalll # D-1189-2012
CODE
1) Lot Expiration; E15678 08/31/2013; E15679 08/31/2013; E156866 08/31/2013; E15687
01/31/2014; E15690 01/31/2014; E15698 01/31/2014; E15700 02/28/2014; E80434 07/31/2013;
E80438 08/31/2013;
F36908 02/28/2014; F36909 02/28/ /2014; F43915 03/31/2014; F43926
03/31/2014; F43927 03/31/2014;
2) Lot Expiration; E15677 08/31/2013; E15704 01/31/2014; E15706
01/31/2014; E80440
08/31/2013; F16388 01/31/2014;
F16390 02/ /28/2014; F22132 02/28/2014; F31330 02/28/2014;
F36911 03/31/2014;
F36913 03/31/2014; F43924 03/31/ /2014; F43925 03/31/2014; F43934
03/31/2014; F53238 03/31/2014
RECALLING FIRM/MANUFACTURERR
Recalling
Firm: Pfizer Inc., New
York, NY, by press release issued on February 1, 2012.
Manufacturer: Pfizer, Inc., Rouses Point, NY. Firm Initiated recall iss ongoing.
REASON
Contraceptive Tablets Out of Sequence: some blister packs may contain an inexact count of inert
or active ingredient tablets and that the tablets may be out of sequence.
PRODUCT (CLAS II)
1) 15% Minoxidil for
Men, Enhanced with Azelaic 5%, Topical Hairr Regrowth Formula, 2 fl oz
60 mL bottles. Recall # D-1190-2012;
2) 10% Minoxidil for
Men, Enhanced with Azelaic 5%, Topical Hairr Re-growth
Formula, 2 fl oz
60 mL glass bottle. Recall # D-1191-2012;
3) 5% Minoxidil for Men, Enhanced with Azelaic 5% Topical Hair Regrowth Formula, 2 fl oz 60
mL glasss bottle. Recall # D-1192-2012;
4) 3% Minoxidil for
Women, Enhances with
Azelaic 1.5%; Hair Regrowth Topical, 2 fl oz 60
mL glasss bottles, Recall # D-1193-2012;
5) Hair Regrowth Shampoo Enhanced with Ketoconazol
le and Salicylic Acid, 6 fl oz. 180 mL,
plastic bottle, Recall # D-1194-2012
CODE
1) All expiration dates up to Oct.
2013;
2) All expiration dates up to Oct.
2013;
3) All expiration dates up to Sept. 2014;
4) All expiration dates up to Nov. 2013;
5) All expiration dates up to Dec. 2013.
RECALLING FIRM/MANUFACTURERR
Recalling
Firm: Perfect Image Solutions LLC, Roseville, CA, by press on January 19, 2012 and
letters on
January 20, 2012.
Manufacturer: Custom Manufacturing Corp, Medley, FL. Firm initiated recall is ongoing.
REASON
Marketed
Without an
Approved NDA/ANDA
A: products are unapproved drugs.
PRODUCT (CLASSS II)
18