Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL...

FDA Drug Recall #D-0232-2024 — Class II — January 11, 2024

Recall Summary

Recall Number D-0232-2024
Classification Class II — Moderate risk
Date Initiated January 11, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Par Sterile Products LLC
Location Rochester, MI
Product Type Drugs
Quantity 1721 cartons

Product Description

Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-237-10

Reason for Recall

Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.

Distribution Pattern

Nationwide USA

Lot / Code Information

Lot # 66702; Exp. 02/2025

Other Recalls from Par Sterile Products LLC

Recall # Classification Product Date
D-0429-2024 Class I Treprostinil Injection, 20 mg/20 mL (1 mg/mL), ... Mar 4, 2024
D-0087-2024 Class II Buprenorphine HCl, Injection, 0.3mg/mL, For Int... Nov 9, 2021
D-0698-2017 Class II Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Si... Apr 28, 2017

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.