Pfizer Recalls Relpax Tablets Due to Microbial Contamination
Pfizer is recalling specific lots of Relpax (eletriptan HBr) tablets because they may be contaminated with Burkholderia and Pseudomonas bacteria.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves microbial contamination with Burkholderia and Pseudomonas, which are high-risk pathogens that can cause serious health issues, fitting the criteria for a Severe rating.
Plain-English summary
Pfizer Inc. is recalling specific lots of Relpax (eletriptan HBr) tablets, 40 mg, due to microbial contamination. The affected products are packaged in 6-count and 12-count cartons and were distributed nationwide in the USA and Puerto Rico.
The recall is being conducted because the tablets may be contaminated with Burkholderia and Pseudomonas bacteria. The specific lots involved are AR5407 and CD4565, both with an expiration date of February 2022. The agency has classified this recall as Class II.
Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected tablets. They should contact their pharmacist or healthcare provider for guidance on replacement or further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: a) AR5407
- Exp 2022 FEB
- b) CD4565
Distribution
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