CORRECTING & REPLACING Lupin Pharmaceuticals Announces a Nationwide Recall of MibelasTM 24 Fe (Norethindrone Acetate & Ethin...
28 May 2017 - 1:09AM
Business Wire
Recall Due to Out of Sequence Tablets and
Missing Expiry/Lot Information
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2017 with the accompanying corrected captions.
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Correct presentation: Mibelas 24 Fe
(Photo: Business Wire)
The release reads:
LUPIN PHARMACEUTICALS INC. ANNOUNCES A
NATIONWIDE RECALL OF MIBELASTM 24 FE
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 1MG/0.02MG CHEWABLE
TABLETS AND FERROUS FUMARATE 75MG) TABLETS
Recall Due to Out of Sequence Tablets and
Missing Expiry/Lot Information
Lupin Pharmaceuticals Inc. announced today that it has
voluntarily recalled lot L600518, Exp 05/18 of Mibelas 24 Fe
(Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable
and ferrous fumarate 75 mg) Tablets at the consumer level. A
confirmed market complaint indicated a packaging error, where the
blister was rotated 180 degrees within the wallet, reversing the
weekly tablet orientation and making the lot number and expiration
date no longer visible. The first four days of therapy would have
had four non-hormonal placebo tablets as opposed to the active
tablets.
As a result of this packaging error, oral contraceptive tablets
that are taken out of sequence may place the user at risk for
contraceptive failure and unintended pregnancy. The reversing the
order may not be apparent to either new users or previous users of
the product, increasing the likelihood of taking the tablets out of
order. For patients in whom a pregnancy is contraindicated or in
whom concomitant medication(s) may have teratogenic effects, an
unintended pregnancy may cause significant adverse maternal or
fetal health consequences, including death. To date there have been
no reports of such adverse events.
This product is an oral contraceptive indicated for the
prevention of pregnancy in women who elect to use oral
contraceptives. These products are packaged in blister packs
containing 28 tablets: 24 white/off-white tablets of active
ingredients debossed with “LU” on one side and “N81” on the other;
and 4 tablets of inert ingredients debossed with “LU” on one side
and “M22” on the other side. This product was distributed
Nationwide in the U.S.A. to wholesalers, clinics and retail
pharmacies.
NDC Lot No
Expiration
68180-911-11 (Wallet of 28
tablets)68180-911-13 (Carton of 3 wallets)
L600518 05/31/2018
Lupin is notifying its distributors and customers by recall
letter and is arranging for return of all recalled products.
Consumers who have the affected product should notify their
physician and return the product to the pharmacy or place of
purchase.
Consumers with questions regarding this recall can contact Lupin
at 1-800-399-2561, 8:00 am to 5:00 pm EDT, Monday through Friday.
Consumers should contact their physician or healthcare provider if
they have experienced any problems that may be related to taking
this drug product.
Adverse events or quality problems experienced with the use of
this product may be reported to the FDA's MedWatch Adverse Event
Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online:
www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form
www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request
a reporting form, then complete and return to the address on the
pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S.
Food and Drug Administration.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170526005444/en/
Lupin PharmaceuticalsConsumer: 1-800-399-2561Media: Arvind
Bothra, arvindbothra@lupin.com