Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Inf...

FDA Drug Recall #D-0638-2017 — Class I — January 24, 2017

Recall Summary

Recall Number D-0638-2017
Classification Class I — Serious risk
Date Initiated January 24, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Hospira Inc., A Pfizer Company
Location Lake Forest, IL
Product Type Drugs
Quantity 30,880 vials

Product Description

Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01

Reason for Recall

Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.

Distribution Pattern

U.S. Nationwide

Lot / Code Information

Lot # 591053A, Exp 11/1/2017

Other Recalls from Hospira Inc., A Pfizer Company

Recall # Classification Product Date
D-0980-2017 Class III Argatroban Injection, 250 mg/2.5 mL (100 mg/mL)... Jul 6, 2017
D-0898-2017 Class II Levophed norepinephrine bitartrate, injection, ... May 18, 2017
D-0480-2017 Class II METRONIDazole Injection, USP 500 mg (5 mg/mL) i... Feb 10, 2017
D-0096-2017 Class II Marcaine 0.25% (bupivacaine HCl) injection, USP... Sep 16, 2016
D-0097-2017 Class II Marcaine 0.5% (bupivacaine HCl) injection, USP,... Sep 16, 2016

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

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.