Canadian Recall: Personelle Acid Control (2013-09-05)

Starting date:
September 5, 2013

Posting date:
September 11, 2013

Type of communication:
Drug Recall

Subcategory:
Drugs

Hazard classification:
Type I

Source of recall:
Health Canada

Issue:
Medical Devices

Audience:
General Public, Healthcare Professionals, Hospitals

Identification number:
RA-35553

Reason

The product is being recalled due to a box design error. The boxes contain inner printing and there is no reference on any outer panel to read the inner printing for important additional information:

What is acid control?

Acid Control (famotidine) tablets are clinically proven to provide fast and effective relief from heartburn and acid indigestion. Acid Control contains the ingredient famotidine which has previously been available only with a prescription. Acid Control works by actually reducing the flow of excess stomach acid which can lead to heartburn pain, unlike antacids which neutralize existing stomach acid. One (1) Acid Control tablet controls stomach acid for up to 9 hours. Acid Control is available in small easy-to-swallow film-coated tablets.

When should a physician or pharmacist be consulted?

This medicine may not be suitable for some people. Consult with your physician or pharmacist before using if:

  • You are allergic to any component of this product.
  • You are pregnant or breast-feeding.
  • You have difficulty swallowing, or have persistent abdominal discomfort.
  • You have severe kidney disease or any other severe illnesses.
  • You are over 40 and you are experiencing new or recently changed symptoms of acid indigestion or heartburn.
  • You are taking nonsteroidal anti-inflammatory drugs [NSAIDs] (because these products may be causing your symptoms).
  • You have a previous history of ulcer disease complications.
  • You are experiencing unintended weight loss in association with your symptoms of acid indigestion or heartburn.
  • Acid Control is generally well tolerated. Should unusual symptoms occur, a physician should be consulted.


What else can be done to help avoid symptoms?

Do not lie down soon after eating.
If you are overweight, lose weight.
If you smoke, stop or cut down.
Avoid or limit foods such as caffeine, chocolate, fatty foods and alcohol.
Do not eat just before bedtime.

Depth of distribution

Distributed to the retail level. Nationally in Canada only.
Affected products
Personelle Acid Control
DIN, NPN, DIN-HIM
DIN 02237223
Dosage form

Tablet
Strength

10 mg

Lot or serial number


1A020B2KQ1
2C177B2Q6R
1K031B2RGF
2C177B2TVS
2H115B2WPW
2H115B2YA9
2H115B2YW1
3D206B32K0

Companies

Recalling Firm
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA

Marketing Authorization Holder
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA