Why it was recalled
Discoloration.
Product description
Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0
Lot numbers, UPCs & expiration codes
Batch: A-200301, A-200307, A-200308, A-200309, A-200395, A-200488, A-200310, A-200311, A-200315, A-200319, A-200397, A-200398
Where it was sold
AL, NJ, TX
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0055-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 2, 2020
- FDA report date
- Nov 11, 2020
- Quantity
- 60,000 kg
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medichem S.A.
Original FDA data
Every field from FDA enforcement report D-0055-2021, exactly as published.
Show all FDA fields
- City
- Barcelona
- Status
- Terminated
- Country
- Spain
- Event ID
- 86540
- Address
- Fructuos Gelabert 6-8
- Code information
- Batch: A-200301, A-200307, A-200308, A-200309, A-200395, A-200488, A-200310, A-200311, A-200315, A-200319, A-200397, A-200398
- Report date
- Nov 11, 2020
- Product type
- Drugs
- Recall number
- D-0055-2021
- Classification
- Class II
- Recalling firm
- Medichem S.A.
- Product quantity
- 60,000 kg
- Termination date
- Dec 16, 2020
- Reason for recall
- Discoloration.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0
- Distribution pattern
- AL, NJ, TX
- Recall initiation date
- Oct 2, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 2, 2020