Digemid Withdraws Pain, Fever Meds Over Quality Fails
DIGEMID Recalls Injectable Medications Due to Quality Concerns
Table of Contents
- DIGEMID Recalls Injectable Medications Due to Quality Concerns
- DIGEMID recalls Injectable Medications: Your Questions Answered
- What is DIGEMID and Why Is It Issuing a Recall?
- Why Were These Injectable Medications Recalled?
- What Medications Are Affected by the Recall?
- Which Lot numbers of Sodium Metamizole Are Being Recalled?
- Which Lot Numbers of Dolofebril are being Recalled?
- What Should I Do If I Have These Medications?
- Where Can I Find the Lot Number on the Medication?
- What Quality Issues Were Identified in These Medications?
- What Does the Closure of the Manufacturing Area Mean?
- Are These Medications Commonly Used?
- What Are the Potential Health Risks Associated with Taking the Recalled Medications?
- What Should I do if I Experience Adverse Reactions?
- What is the Peruvian Pharmacovigilance and Tecnovigilance System?
- How can I Report Adverse reactions to the Recalled Medications?
- What is DIGEMID Doing to Address the Situation?
LIMA, Peru – the General Directorate of Medicines, Supplies and Drugs (DIGEMID), a division of the Ministry of Health, has announced a recall of specific lots of injectable medications following the discovery of quality defects. The affected products, manufactured by Laboratories United SA, are commonly used to treat pain and fever.
Affected Medications and lot numbers
According to DIGEMID alert No. 59-2025, the recall involves specific lots of Sodium Metamizole 1g/2ml and Dolofebril 1g/2ml injectable solutions.The agency reported the presence of precipitate in the solutions, indicating a failure in the manufacturing process.
The following lots are subject to the recall:
- Sodium Metamizole 1 g/2 ml injectable solution (Sanitary Registry EN-08009):
- 2081433
- 2070263
- 2081353
- 2081423
- 2090043
- 2120023
- 2081453
- Dolofebril 1G/2ML INJECTABLE SOLUTION (Sanitary Registry EN-08555):
- 2081463
- 2081493
Manufacturing Area temporarily Closed
As a result of the identified quality issues,DIGEMID has ordered the temporary closure of the non-beta-lactamic pharmaceutical products manufacturing area,specifically the sterile liquids section,at Laboratories United SA.
Public Advisory
DIGEMID is urging the public to immediately cease using the recalled medications from the specified lot numbers. Individuals who have acquired thes products are advised to refrain from using them.
The agency also encourages anyone experiencing adverse reactions potentially linked to these medications to report them to the Peruvian Pharmacovigilance and Tecnovigilance System through DIGEMID’s official platforms.
“There is the possibility that these products with the mentioned health observations have been acquired or are in possession of patients, it is recommended to refrain from using them. The DIGEMID remembers that the suspicions of adverse reactions associated with the use of pharmaceutical products must be reported to the Peruvian Pharmacovigilance and Tecnovigilance System.”
DIGEMID continues to investigate the matter and work to ensure the safety and quality of pharmaceutical products available to the public.
DIGEMID recalls Injectable Medications: Your Questions Answered
What is DIGEMID and Why Is It Issuing a Recall?
The General Directorate of Medicines, Supplies and Drugs (DIGEMID), a division of the Ministry of Health in Peru, is responsible for regulating and ensuring the quality and safety of medications available to the public.DIGEMID announced a recall of specific injectable medications due to identified quality defects found in certain batches.
Why Were These Injectable Medications Recalled?
DIGEMID initiated the recall due to the finding of quality defects, specifically the presence of precipitate in the injectable solutions. This indicates a failure in the manufacturing process of these medications.
What Medications Are Affected by the Recall?
The recall affects specific lots of two injectable medications manufactured by Laboratories United SA.These medications are:
- Sodium Metamizole 1g/2ml injectable solution
- Dolofebril 1g/2ml injectable solution
Which Lot numbers of Sodium Metamizole Are Being Recalled?
The following lot numbers of Sodium Metamizole 1 g/2 ml injectable solution (Sanitary Registry EN-08009) are subject to the recall:
- 2081433
- 2070263
- 2081353
- 2081423
- 2090043
- 2120023
- 2081453
Which Lot Numbers of Dolofebril are being Recalled?
The following lot numbers of Dolofebril 1G/2ML INJECTABLE SOLUTION (Sanitary Registry EN-08555) are subject to the recall:
- 2081463
- 2081493
What Should I Do If I Have These Medications?
DIGEMID is urging the public to immediately stop using the recalled medications from the specified lot numbers. If you have any of these products, it is indeed recommended that you refrain from using them.
Where Can I Find the Lot Number on the Medication?
The lot number is typically printed on the medication packaging, frequently enough near the expiration date.
What Quality Issues Were Identified in These Medications?
The primary quality issue is the presence of a “precipitate” in the solution. This means that solid particles have formed within the liquid injectable medication, which is not normal and suggests a problem during the manufacturing, storage, or transport of the product. This could make the medication less effective or potentially unsafe.
What Does the Closure of the Manufacturing Area Mean?
DIGEMID has ordered the temporary closure of the non-beta-lactamic pharmaceutical products manufacturing area, specifically the sterile liquids section, at Laboratories United SA. This action is a direct result of the identified quality issues to prevent the distribution of potentially defective medications.
Are These Medications Commonly Used?
Yes, the affected medications, Sodium Metamizole and Dolofebril, are used to treat pain and fever, making them a commonly prescribed and readily available type of medication.
What Are the Potential Health Risks Associated with Taking the Recalled Medications?
The exact health risks are not detailed in the provided documentation, but the presence of precipitate suggests a manufacturing defect that could reduce the medication’s effectiveness or cause local tissue irritation or allergic reaction upon injection. It is crucial to refrain from using these medications.
What Should I do if I Experience Adverse Reactions?
DIGEMID strongly encourages anyone experiencing adverse reactions potentially linked to these medications to report them to the Peruvian Pharmacovigilance and Tecnovigilance System through DIGEMID’s official platforms. See the text from DIGEMID’s official source below.
“There is the possibility that these products with the mentioned health observations have been acquired or are in possession of patients, it is recommended to refrain from using them. The DIGEMID remembers that the suspicions of adverse reactions associated with the use of pharmaceutical products must be reported to the Peruvian Pharmacovigilance and Tecnovigilance System.”
What is the Peruvian Pharmacovigilance and Tecnovigilance System?
This is the official system for collecting and analyzing reports of adverse drug reactions and other safety concerns related to medicines and medical devices in Peru. Reporting to this system helps ensure the safety of other patients and enables DIGEMID to take appropriate action.
How can I Report Adverse reactions to the Recalled Medications?
the article states that you should report adverse reactions to the Peruvian pharmacovigilance and Tecnovigilance System through DIGEMID’s official platforms. More information on how to report may be found on the DIGEMID website, which is https://www.digemid.minsa.gob.pe/webDigemid/farmacovigilancia-y-tecnovigilancia/.
What is DIGEMID Doing to Address the Situation?
DIGEMID is currently investigating the matter to determine the cause of the quality defects. The agency is working to ensure the safety and quality of pharmaceutical products available to the public. they have also taken steps to temporarily close the affected manufacturing area.
Here is a summary of the affected medications and lot numbers:
| Medication | Sanitary Registry | Affected Lot Numbers |
|---|---|---|
| Sodium Metamizole 1 g/2 ml injectable solution | EN-08009 | 2081433, 2070263, 2081353, 2081423, 2090043, 2120023, 2081453 |
| Dolofebril 1G/2ML INJECTABLE SOLUTION | EN-08555 | 2081463, 2081493 |