Teva Pharmaceuticals USA, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply

PARSIPPANY, N.J.–(BUSINESS WIRE)–Teva Pharmaceuticals USA, Inc. has initiated a voluntary recall in the
United States, to the patient level, of 35 lots of bulk Losartan
Potassium USP Tablets (6 lots of 25 mg strength and 29 lots of 100 mg
strength). This recall is due to the detection of an impurity –
N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – found in six lots of
active pharmaceutical ingredient (API) manufactured by Hetero Labs
Limited that is above the US Food & Drug Administration’s interim
acceptable exposure limit of 9.82 ppm. Based on the available
information, the risk of developing cancer in a few patients following
long-term use of the product cannot be ruled out.

Losartan Potassium is indicated for the treatment of hypertension,
hypertensive patients with left ventricular hypertrophy, and nephropathy
in Type 2 diabetic patients. The lots were sold exclusively to Golden
State Medical Supply of Camarillo, California. Golden State Medical
Supply packages this bulk product under its own label and distributes in
retail bottles of 30, 90, and 1000 tablets.

To date, Teva has not received any reports of adverse events related to
the lots being recalled.

No other Teva Losartan Potassium finished drug products have been
identified, in the United States, containing API above the interim
specification levels set for NMBA.

The affected Losartan Potassium tablets being recalled are described as:

• • Losartan Potassium tablets, USP 25 mg, are light-green, film-coated,
    teardrop-shaped biconvex tablet with “LK 25” on one side and “>” on
    the other side.

• • Losartan Potassium tablets, USP 100 mg, are dark green, film-coated,
    oval-shaped biconvex tablets with “LK100” on one side and “>” on the
    other side.

Teva promptly notified Golden State Medical Supply of the presence of
the impurity in Hetero’s API and Teva will recall thirty-five (35) lots
of bulk Losartan Potassium tablets sold to that company. The tablets,
which have been packaged and sold by Golden State Medical Supply, will
be recalled from their customers and patients. Distributors and
retailers that have product being recalled should immediately stop
distribution, quarantine all remaining product in their control, and
return the recalled product per the instructions given to them by Golden
State Medical Supply.

Patients taking Losartan Potassium tablets are advised to continue
taking their medication and contact their pharmacist, physician, or
medical provider for advice regarding an alternative treatment. The
immediate risk of harm to a patient’s health is likely to be higher if
the medicine is stopped abruptly without any alternative treatment. For
full drug product information, please refer to the full prescribing
information for Losartan Potassium tablets USP.

Customers and patients with medical-related questions, who wish to
report an adverse event, or quality issues about the Teva products being
recalled under the Golden State Medical Supply label should contact Teva
Medical Information by phone at: 888-838-2872, option 3, then, option 4.
Live calls are received Monday-Friday, 9:00AM-5:00PM Eastern Time with
voicemail available 24 hours/day, 7 days/week or by email at [email protected].

Adverse reactions or other problems experienced with the use of these
products should also be reported to the FDA’s MedWatch Adverse Event
Reporting program 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-1088.

Patient safety and product quality are critical to Teva. As always, Teva
and Golden State Medical Supply will continue to partner with, and
regularly update, all relevant stakeholders, including regulatory
authorities, to resolve this situation.

Lots Under Voluntary Recall

The finished product lots that are included in this voluntary recall and
listed below were sold by Teva in bulk containers. The tablets were
repackaged for further distribution by Golden State Medical Supply under
its product label. The bulk tablet lots were repackaged into 44 finished
products lots for further distribution by Golden State Medical Supply
under its product label.

Note – “GSMS FG” refers to Golden State Medical Supply Finished Goods.

Patients wishing to return product may contact Teva’s product recall
processor to obtain instructions and a return kit for returning their
medication:

• • Contact Inmar at 877-789-2065 (Hours of operation: 9 am to 5 pm
    Eastern Time, Monday – Friday) or email Inmar at: [email protected].

• • Inmar will provide the materials needed to return their medication and
    instructions for reimbursement.

• • Customers of Golden State Medical Supply may:
    • • Call: (800) 284-8633, ext. 215
    • • Fax: (805) 437-7582
    • • Email: [email protected]

Product labels associated with the lots being recalled will be posted to
the FDA website under Recalls and Alerts.

Contacts

Consumers
Teva’s Medical Information
[email protected]
888-838-2872

Media:
Eric Rubin
973-265-3759

Kelley Dougherty
973-658-0237