Apo-Tiotropium Capsules; Out-of-specification (particle size)
Brand(s)
Last updated
Summary
Product
Apo-Tiotropium 18 mcg Capsules
Issue
Health products - Product quality
What to do
Consult your healthcare provider prior to discontinuing use of the affected product, or for any health concerns.
Affected products
| Brand | Product Name | Market Authorization | Dosage Form | Strength | Lot Number |
|---|---|---|---|---|---|
| Apotex Inc. | Apo-Tiotropium capsule | DIN 02550865 | Capsule | Tiotropium bromide monohydrate 18 mcg | LC87540 LC87541 LC87616 LC88196 LC88197 LC88316 LC88318 LC88319 LC89638 LC89639 LC89640 LC89641 LC89671 LC89681 LC89725 LC89783 |
Issue
The particle size did not meet the specifications in the affected lots.
What you should do
- Verify if your product is affected.
- Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
- Contact the recalling firm if you have any questions about the recall.
- Report any health product related side effects to Health Canada.
- Report any other health product safety complaints to Health Canada.
Additional information
Background
Depth of recall: Retailers
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
Apotex Inc.
150 Signet Drive
Toronto ON, M9L 1T9
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-82325
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