Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Phar...

FDA Drug Recall #D-0641-2017 — Class I — February 3, 2017

Recall Summary

Recall Number D-0641-2017
Classification Class I — Serious risk
Date Initiated February 3, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm SCA Pharmaceuticals
Location Little Rock, AR
Product Type Drugs
Quantity 716 bags

Product Description

Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59

Reason for Recall

Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

Distribution Pattern

U.S. Nationwide

Lot / Code Information

Lot: 20161213@23, Exp 2/11/2017; Lot: 20161214@80, Exp 2/12/2017; Lot: 20161215@1, Exp 2/13/2017

Other Recalls from SCA Pharmaceuticals

Recall # Classification Product Date
D-0945-2023 Class II FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% ... Jul 20, 2023
D-0555-2023 Class III Oxytocin 30 units added to 0.9% Sodium Chloride... Apr 10, 2023
D-0363-2023 Class III Fentanyl 1,500 mcg/30 mL syringe, Injection for... Feb 24, 2023
D-0830-2022 Class II Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9%... Apr 25, 2022
D-0831-2022 Class II Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 5... Apr 25, 2022

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.