Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL pre...

FDA Drug Recall #D-0925-2018 — Class II — July 5, 2018

Recall Summary

Recall Number D-0925-2018
Classification Class II — Moderate risk
Date Initiated July 5, 2018
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Sanofi-Aventis U.S. LLC
Location Bridgewater, NJ
Product Type Drugs
Quantity 3214 prefilled pens

Product Description

Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00

Reason for Recall

Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.

Distribution Pattern

Nationwide

Lot / Code Information

Lot #: 7F021B, Exp 6/30/20

Other Recalls from Sanofi-Aventis U.S. LLC

Recall # Classification Product Date
D-0575-2023 Class II Admelog, insulin lispro injection, 100 units/mL... Apr 11, 2023
D-1507-2020 Class II Elitek (rasburicase) for injection, 7.5 mg vial... Aug 10, 2020
D-0534-2020 Class II Cool Mint Tablets Maximum Strength Zantac 150 m... Oct 22, 2019
D-0540-2020 Class II Regular Strength Zantac 75 mg, Distributed by: ... Oct 22, 2019
D-0542-2020 Class II Regular Strength Zantac 75 mg, Distributed by: ... Oct 22, 2019

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.