Why it was recalled
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Product description
RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12-count (2 cards x 6 tablets) per carton, NDC 0049-2340-05, Rx only, Made in Ireland, Distributed by Pfizer Roerig, Division of Pfizer Inc., NY, NY 10017.
Lot numbers, UPCs & expiration codes
Lot #: a) AR5407, Exp 2022 FEB; b) CD4565, Exp 2022 FEB
Where it was sold
Nationwide in the USA and Puerto Rico.
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-1845-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 14, 2019
- FDA report date
- Sep 4, 2019
- Quantity
- a) 20,117 cartons; b) 2,502 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1845-2019, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 83533
- Address
- 235 E 42nd St
- Code information
- Lot #: a) AR5407, Exp 2022 FEB; b) CD4565, Exp 2022 FEB
- Postal code
- 10017-5703
- Report date
- Sep 4, 2019
- Product type
- Drugs
- Recall number
- D-1845-2019
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- a) 20,117 cartons; b) 2,502 cartons
- Termination date
- Jun 20, 2023
- Reason for recall
- Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12-count (2 cards x 6 tablets) per carton, NDC 0049-2340-05, Rx only, Made in Ireland, Distributed by Pfizer Roerig, Division of Pfizer Inc., NY, NY 10017.
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Aug 14, 2019
- Initial firm notification
- Press Release
- Center classification date
- Aug 28, 2019