Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Si...

FDA Drug Recall #D-1046-2017 — Class II — June 15, 2017

Recall Summary

Recall Number D-1046-2017
Classification Class II — Moderate risk
Date Initiated June 15, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Hospira a Pfizer Company
Location Rocky Mount, NC
Product Type Drugs
Quantity 20,337,650 15 mL single dose vials

Product Description

Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx Only, Mfd by Hospira, Inc. Lake Forest, IL 60045 USA, NDC: 0409-7295-01

Reason for Recall

Lack of Sterility Assurance

Distribution Pattern

U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore

Lot / Code Information

Lot: 74119EV Exp. 02/01/2019 Lot: 74120EV Exp. 02/01/2019 Lot: 74121EV Exp. 02/01/2019 Lot: 74307EV Exp. 02/01/2019 Lot: 75326EV Exp. 03/01/2019 Lot: 75327EV Exp. 03/01/2019 Lot: 75215EV Exp. 03/01/2019

Other Recalls from Hospira a Pfizer Company

Recall # Classification Product Date
D-1047-2017 Class II 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-... Jun 15, 2017
D-1049-2017 Class II Neut Sodium Bicarbonate 4% (2.4 mEq) Additive S... Jun 15, 2017
D-1048-2017 Class II Succinylcholine Chloride Injection, USP 200 mg ... Jun 15, 2017

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.