Why it was recalled
Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
Product description
Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Celra, 17460, Celra, Girona (Spain/Espana); Fructuos Gelabert, 6-8, 08970, Sant Joan Despi, Barcelona (Spain/Espana) NDC 53296-0012-0
Lot numbers, UPCs & expiration codes
A-190571, exp. 11/29/21, A-190418, exp. 09/04/21, A-190503, exp. 10/25/21, A-190576, exp. 12/02/21, A-190537, exp. 11/15/21, A-200082, exp. 02/24/22, A-200085, exp. 02/25/22, A-200097, exp. 03/05/22, A-200116, exp. 03/13/22, A-200127, exp. 03/19/22, A-200131, exp. 03/20/22
Where it was sold
Nationwide
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-1534-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 24, 2020
- FDA report date
- Sep 2, 2020
- Quantity
- 117,800 kg
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medichem S.A.
Original FDA data
Every field from FDA enforcement report D-1534-2020, exactly as published.
Show all FDA fields
- City
- Barcelona
- Status
- Terminated
- Country
- Spain
- Event ID
- 85869
- Address
- Fructuos Gelabert 6-8
- Code information
- A-190571, exp. 11/29/21, A-190418, exp. 09/04/21, A-190503, exp. 10/25/21, A-190576, exp. 12/02/21, A-190537, exp. 11/15/21, A-200082, exp. 02/24/22, A-200085, exp. 02/25/22, A-200097, exp. 03/05/22, A-200116, exp. 03/13/22, A-200127, exp. 03/19/22, A-200131, exp. 03/20/22
- Report date
- Sep 2, 2020
- Product type
- Drugs
- Recall number
- D-1534-2020
- Classification
- Class I
- Recalling firm
- Medichem S.A.
- Product quantity
- 117,800 kg
- Termination date
- Apr 9, 2021
- Reason for recall
- Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Celra, 17460, Celra, Girona (Spain/Espana); Fructuos Gelabert, 6-8, 08970, Sant Joan Despi, Barcelona (Spain/Espana) NDC 53296-0012-0
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 24, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 21, 2020