Recall of DHEA 50mg in bottle of 60’s

Retail-level recall of one batch of DHEA 50mg in bottle of 60’s due to black spots in capsule

Date of recall:

10 March 2023

Product:

DHEA 50mg in bottle of 60’s

Active Ingredient:

DHEA

Product Category:

Therapeutic product

Batch No.:

43063

Class of Recall:

2

Level of Recall:

Retail

Local Company:

Amber Compounding Pharmacy

Description of Issue:

Black spots are detected in the capsule content

Recall Instructions:

Hospitals, clinics, pharmacies

Stop supplying the affected batch and return the remaining stocks to the company.

Note:

Class of recall

A recall is classified as Class 1 or Class 2 depending on the potential hazard of the issue.

  • Class 1: For recalls of products with issues that can potentially cause serious adverse health outcomes or death.
  • Class 2: For recalls of products with issues that would not likely cause serious adverse health outcomes.

 

Level of recall

The level of product recall will depend on the potential hazard of the affected product, extent of distribution and whether other mitigating measures can be taken to address the issue.

  1. Consumer level: Affected product or batch(es) recalled from patients and consumers as well as wholesale suppliers, retail suppliers, hospitals, clinics and pharmacies.
  2. Retail level: Affected product or batch(es) recalled from retail suppliers, hospitals, clinics and pharmacies as well as wholesale suppliers.
  3. Wholesale level: Affected product or batch(es) recalled from wholesale suppliers.
Healthcare professional, Therapeutic Products
Published:

Product Recalls