Public Advisories

July 31, 2013

Health Canada Endorsed Important Safety Information on MIACALCIN® Nasal Spray, SANDOZ CALCITONIN Nasal Spray, APO-CALCITONIN Nasal Spray

The manufacturers of synthetic calcitonin (salmon) Nasal Spray (NS) Products (listed above), in collaboration with Health Canada, would like to advise you of the market withdrawal of these Products, effective October 1st, 2013.

June 24, 2013

Recall of APO-CEPHALEX (cephalexin) due to possible reduced drug efficacy (DINs: 00768715 and 00768723)

Apotex Inc., in consultation with Health Canada, is writing to advise you that Apotex has initiated a recall for two lots of APO-CEPHALEX (cephalexin); the lot numbers are JP6665 for APO-CEPHALEX 250 MG and JP1017 for APO-CEPHALEX 500 MG tablets. Inadvertent exposure of these APO-CEPHALEX tablets to rain water may have caused tablets to partially dissolve and have a decreased active drug content which may in turn result in reduced drug efficacy.

June 19, 2013

KETOCONAZOLE and the Risk of potentially Fatal Liver Damage

Apotex Inc. and Teva Canada Limited, in collaboration with Health Canada, would like to inform you of additional safety information regarding the marketed medication KETOCONAZOLE (APO-KETOCONAZOLE and NOVO-KETOCONAZOLE).

May 31, 2013

APO-K Potassium Chloride Slow-Release Tablets

Apotex is notifying all direct account Retailers, Wholesalers and Distributors that have received an impacted lot of a voluntary TYPE II recall being conducted to the Retail Level for the selected lots of APO-K (Potassium Chloride Slow-Release Tablets). This voluntary TYPE II recall is being conducted in coordination with the Health Product and Food Branch Inspectorate Canada.

May 31, 2013

APO-CEPHALEX (Cephalexin Tablets USP)

Apotex is notifying all direct account Retailers, Wholesalers and Distributors that have received an impacted lot of a voluntary TYPE II recall being conducted to the Retail Level for the selected lots of APO-CEPHALEX (Cephalexin Tablets USP). This voluntary TYPE II recall is being conducted in coordination with the Health Product and Food Branch Inspectorate Canada.

May 25, 2013

Health Canada Endorsed Important Safety Information on APO-CLINDAMYCIN, CLINDAMYCINE-150, and CLINDAMYCINE-300

Subject: Important safety information for patients who are prescribed APO-CLINDAMYCIN, CLINDAMYCINE-150 and CLINDAMYCINE-300 capsules and who have a history of allergy to quetiapine.

Apotex Inc. and Pro Doc Ltée, in consultation with Health Canada, wishes to advise you that their supplier of clindamycin hydrochloride may have inadvertently caused trace amounts of the anti-psychotic drug quetiapine to be present in the clindamycin raw material. Exposure to quetiapine in patients known to be allergic should be avoided.

APO-CLINDAMYCIN, CLINDAMYCINE-150 and CLINDAMYCINE-300 contain clindamycin hydrochloride, an antibiotic, which is used to treat many infections. Some examples of uses of clindamycin are to treat infections in patients who are allergic to penicillin, in cases when other antibiotics are not effective, before dental, oral and upper respiratory tract surgery, and for pneumonia in AIDS patients.

Clindamycin is considered a medically necessary drug. As Apotex and Pro Doc currently supply about 75% of the Canadian market needs for clindamycin, taking steps to ensure continued patient access to this medication is of utmost importance. As a result, this advisory is only directed to the specific group of patients identified in the bullets below.

  • Trace amounts of the drug quetiapine may be present in APO-Clindamycin, Clindamycine-150 and Clindamycine-300
  • If you are allergic to quetiapine do not take APO-Clindamycin, Clindamycine-150 and Clindamycine-300. If you are allergic to quetiapine and presently taking APO-Clindamycin, Clindamycine-150 and Clindamycine-300 please contact your pharmacist immediately
  • If you are unsure if you are allergic to quetiapine please contact your health care professional to find out

Background

An inspection of a Pharmaceutical Factory in China was conducted by the European Directorate for the Quality of Medicines and Healthcare (EDQM) recently. During this inspection, a concern was identified about possible contamination of clindamycin with quetiapine. This contamination may have resulted from trace amounts of quetiapine on common equipment.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious allergic reactions or other serious or unexpected adverse reactions in patients receiving APO-Clindamycin should be reported to Apotex Inc. or Health Canada, Clindamycine-150 and Clindamycine-300 should be reported to Pro Doc Ltée or Health Canada.

If you have experienced an adverse reaction with APO-CLINDAMYCIN, please contact Apotex Drug Safety department as per the contact information below:

APOTEX INC.
150 Signet Drive
Weston, Ontario
M9L 1T9

Phone: 1-800-667-4708
Fax: 1-416-401-3819
Email: Drugsafety@apotex.com

If you have experienced an adverse reaction with CLINDAMYCINE-150 or CLINDAMYCINE-300, please contact Pro Doc Ltée as per the contact information below:

PRO DOC LTÉE
2925, Boul. Industriel
Laval, Québec
H7L 3W9

Phone: 1-800-361-8559
Fax: 1-888-977-6362
Email: medinfo@prodoc.qc.ca

You can report any suspected side effect associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, please contact Health Canada at:

Health Products and Food Branch Inspectorate Directorate
E-mail: DCVIU_UVECM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 613-946-5636

Yours sincerely,
original signed by
Colin D'Cunha MBBS, MHSc, FRCPC
Director Global Medical Affairs

Marcel Lapointe, pharmacist
Director, Professional Services
Pro Doc Lt´e

Warning: This Public Communication is not intended as medical advice. In order to understand the implications of this information to your health and before you modify the way you use this health product, it is important that you consult your doctor or health care professional.

April 12, 2013

Alysena™28 Recall Update

On April 9, 2013, Apotex issued a public advisory regarding a Type I & II voluntary recall of one lot of ALYSENA 28 (levonorgestrel and ethinyl estradiol tablets USP) birth control pills – specifically, lot number LF01899A – due to a packaging flaw. In parallel with this recall, Apotex has been working closely with the third party fabricator, Laboratorios Leon Farma, S.A., to ensure all necessary quality controls for this product are effective.

To date, there is no evidence that the packaging flaw with this one lot of ALYSENA 28, which involved an incorrect placement and number of active tablets (pink) and placebo tablets (white) in the blister, is repeated in any other lots of ALYSENA 28. However, as a precautionary measure while Apotex investigates why the original lot of ALYSENA 28 contained blisters with extra placebo tablets (white) in place of active tablets (pink), Apotex is now expanding the scope of the voluntary Type I & II recall to all lots of ALYSENA 28 distributed to date, having the following lot numbers:

LF01901A, LF01900A, LF01898A, LF01894B, LF01980A, LF01982A, LF01981A, LF01979A, LF02037A, LF02036A, LF02026A

Furthermore, Apotex is undertaking a full visual inspection of each blister from all new lots of ALYSENA 28 that Apotex has received from the third party fabricator, to ensure there are no other packaging flaws or other defects before these lots are distributed in Canada.

Apotex is proactively taking these additional measures to ensure that this product meets Apotex's high quality standards.

ALYSENA 21, which is manufactured by the same third party fabricator at the same facility, is not part of the current recall, as the blisters for this product do not normally include a row of placebo tablets (white). However, because this product is made in the same facility as ALYSENA 28, Health Canada and Apotex are working together to verify this product as well. Individuals are encouraged to check their blisters of ALYSENA 21 to confirm that they contain three rows of seven active tablets (pink), for a total of 21 pink tablets.

According to the product monograph for ALYSENA 28, in the case of a missed dose, individuals should use a non-hormonal method of contraception as an interim measure until they speak with their pharmacist and/or physician and obtain medical advice.

For sexually active individuals, missing a week of active tablets (pink) would place an individual at the same risk level of becoming pregnant as an individual who is not using contraception.

Apotex is asking any individuals who have received any of the identified lots of ALYSENA 28 to speak with their pharmacist and/or physician and return the blister packets to their pharmacy. Apotex has also established a toll-free recall information service at 1-866-367-4537 to provide patients and health care professionals with additional support.

Correct ALYSENA 28 blister pack configuration
Correct ALYSENA 28 blister pack configuration

Correct ALYSENA 21 blister pack configuration
Correct ALYSENA 21 blister pack configuration

 

April 9, 2013

Alysena™28

Apotex had initiated a voluntary Type II recall to the retail and pharmacy level for Alysena™ 28 (lot LF01899A), on behalf of the fabricator, Laboratorios Leon Farma S.A., due to the potential for packaged unit to contain two rows of placebo instead of one row (14 tablets instead of 7 tablets) and two rows of active contraceptive tablets (14 tablets instead of 21 tablets) in the blister pack.

Apotex has been swift to respond to Health Canada's additional classification of Type I assigned to a proportion of the patient population associated with patients who should not get pregnant, whether for medical reasons or exposure to agents detrimental to a developing fetus (such as those on pregnancy prevention programmes while taking drugs that can cause harm to a developing fetus).

As such, and according to the product monograph, in the case of a missed dose, use a non-hormonal method of contraception as an interim measure until you speak with your pharmacist / physician and obtain medical advice. If you have received this lot (LF01899A) we are asking those patients to speak with their pharmacist and or physician and return any units of this lot to their pharmacist.


We would ask that if you have received ALYSENA™ 28 lot LF01899A or have questions regarding this recall, please contact Stericycle at 1-866-367-4537.

Correct Alysena™28 blister pack configuration
Correct Alysena™28 blister pack configuration

Rows 1, 2 and 3: Seven (7) pink tablets per row (21 active pills) ; Row 4: Seven (7) white tablets (inactive/placebo pills).
Any other configuration is incorrect, and should be returned to pharmacy.

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