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Type II Product Recall of Apo-Lithium Carbonate SR 300 mg strength tablets - For Health Professionals
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(PDF Version - 35 K)Contact: Health Product and Food Branch Inspectorate (HPFBI)
The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Apotex Inc.
Contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information on Apo-Lithium Carbonate SR 300 mg strength tablets
26 October 2009
Dear Health Care Professional,
Subject: Type II Product Recall of Apo-Lithium Carbonate SR 300 mg strength tablets.
| Product | Strength | DIN | Package Type | Lot/Batch Nos. | Expiry date |
|---|---|---|---|---|---|
| Apo-Lithium Carbonate SR | 300 mg | 02266695 | Bottles of 100 tablets | HT 9748 | 2010/03 |
| HV 7090 | 2010/05 | ||||
| HX 9290 | 2010/07 |
Apotex Inc., in collaboration with Health Canada, wishes to advise health care professionals that a recall of Apo-Lithium Carbonate SR 300 mg strength tablets was initiated on 20 October 2009 due to stability issues which may have had an impact on the quality of the product. Given the recall, a shortage of sustained release preparation of lithium may occur in which case patients taking Apo-Lithium Carbonate SR 300 mg may need to be switched to an alternate lithium preparation. Alternate lithium options include other sustained release preparations or immediate release preparations. In the event that a patient is switched to an immediate release formulation of lithium carbonate, titration of dose, careful monitoring of lithium blood levels, adverse effects and compliance is advised.
Apo-Lithium Carbonate is indicated in the lithium treatment of manic episodes of manic-depressive illness. Maintenance therapy has been found to be useful in preventing or diminishing the frequency of subsequent relapses in bipolar manic-depressive patients (with a history of mania).1
- Pharmacists are requested to refer patients to their physicians immediately for alternate therapy if they are unable to fill a patient's prescription with Lithium Carbonate SR 300 mg.
- Physicians are requested to be accessible to their patients who may need to be switched from the sustained release product to an immediate release version.
- In light of the narrow therapeutic index when using lithium, physicians are reminded to titrate lithium doses carefully and to monitor lithium blood levels closely, if and when a change is made to immediate release lithium formulations.
Managing marketed health product-related adverse reactions depend 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. We encourage the reporting of adverse effects to either Apotex Inc. or Health Canada at the following addresses:
Apotex Inc.
150 Signet Drive
Toronto, ON
M9L 1T9
Telephone: 1-800-667-4708
Fax: 416-401-3819
E-mail: drugsafety@apotex.com
Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 866-234-2345
Fax: 866-678-6789
CanadaVigilance@hc-sc.gc.ca
The Adverse Reaction Reporting Form and the Adverse Reaction Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.
For other inquiries related to this communication, please contact Health Canada at:
Health Product and Food Branch Inspectorate (HPFBI)
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 613-946-5636
Sincerely,
original signed by
Lance Lovelock
Vice President Quality Assurance
original signed by
Colin D'Cunha MBBS,MHSc,FRCPC
Director - Global Pharmacovigilance
References:
1. Canadian Product Monograph, Apo-Lithium Carbonate SR, 300 mg. Revised November 22, 2005; page 5
