One lot of pms-PROGESTERONE 100 mg capsules recalled because it may pose serious risks to individuals with severe peanut allergies

Starting date:
August 24, 2021
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Product Safety, Allergy Information, Unauthorized products, Undeclared Substance
Audience:
General Public
Identification number:
RA-76301

Last updated:

Summary

  • Product: pms-PROGESTERONE 100 mg capsules (DIN 02476576)
  • Issue: Pharmascience Inc. is recalling one lot (1318593, expiry 10/2022) of pms-PROGESTERONE 100 mg capsules because the bottles may contain capsules from another manufacturer, Akorn 100 mg progesterone capsules. The Akorn capsules contain peanut oil, which poses serious risks to individuals with severe peanut allergies. Akorn 100 mg progesterone is not authorized for sale in Canada. The pms-PROGESTERONE 100 mg capsules are round and beige with “100” printed in black on the capsule, while the Akorn 100 mg progesterone capsules are round and pink with “AK” printed in black on the capsule.
  • What to do:
    • If you have severe peanut allergies, stop using your medication and return it to the pharmacy to get a replacement bottle.
    • If you do NOT have peanut allergies and you find any Akorn progesterone capsules (pink marked with “AK”), return your bottle to the pharmacy for disposal of the Akorn progesterone doses and to receive replacement doses of pms-PROGESTERONE.

Issue

Pharmascience Inc. is recalling one lot (1318593, expiry 10/2022) of pms-PROGESTERONE 100 mg capsules because the bottles may contain Akorn 100 mg progesterone gelatin capsules in addition to or instead of the intended pms-PROGESTERONE 100 mg gelatin capsules. The Akorn capsules contain peanut oil, an ingredient that is not listed on the label of pms-PROGESTERONE 100 mg capsules. Peanuts may cause life-threatening allergic reactions (anaphylaxis) in individuals with severe peanut allergies.

pms-PROGESTERONE is a prescription hormone drug used as part of hormone replacement therapy for menopause in women.

The pms-PROGESTERONE 100 mg capsules are round and beige with “100” printed in black on the capsule, while the Akorn 100 mg progesterone capsules are round and pink with “AK” printed in black on the capsule.

The Pharmascience and Akorn capsules contain the same dose of the active ingredient, progesterone. Akorn 100 mg progesterone capsule is not authorized for sale in Canada and therefore it has not been reviewed by Health Canada for its safety, efficacy and quality.

Health Canada is monitoring the recall. If additional safety information is identified, Health Canada will take appropriate action and inform Canadians as needed.

Affected products

Company Product DIN Lot Expiry
Pharmascience Inc. pms-PROGESTERONE 100 mg capsules
100-capsule bottles
02476576 1318593 10/2022

What you should do

  • If you have severe peanut allergies, stop using your medication and return it to the pharmacy to get a replacement bottle.
  • If you do NOT have peanut allergies and if you find any Akorn progesterone capsules (pink marked with “AK”), return your bottle to the pharmacy for disposal of the Akorn progesterone doses and to receive replacement doses of pms-PROGESTERONE.
  • Consult a health care professional if you have used these products and have health concerns.
  • Contact Pharmascience Inc. by calling, toll-free, 1-800-340-9735, or by email at customercarePms@pharmascience.com if you have questions about the recall.
  • Report any health product-related side effects or complaints to Health Canada.

Media enquiries

Health Canada
(613) 957-2983
media@hc-sc.gc.ca

Public enquiries

(613) 957-2991
1-866 225-0709
hcinfo.infosc@canada.ca

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