Class II
Terminated
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.
- Company
- Pfizer Inc.
- Recall Initiated
- August 14, 2019
- Posted
- September 4, 2019
- Recall Number
- D-1845-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 20,117 cartons; b) 2,502 cartons
- Firm Location
- New York, NY, United States
Reason for Recall
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Distribution
Nationwide in the USA and Puerto Rico.
Lot / Code Info
Lot #: a) AR5407, Exp 2022 FEB; b) CD4565, Exp 2022 FEB
More recalls by Pfizer Inc.
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc.,...
Aug 27, 2025 · Class II
Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx...
Aug 6, 2025 · Class II
DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Flipt...
Jul 2, 2025 · Class II
Other recent Class II Drug recalls
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...
Wizcure Pharmaa Private Limited
· Mar 4, 2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...
Avkare
· Mar 4, 2026
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...
Agebox
· Mar 4, 2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL...
Leo Pharma Inc
· Mar 4, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...
Pro Numb Tattoo Numbing Spray Llc
· Feb 18, 2026