GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

FDA Drug Recall #D-0135-2021 — Class II — November 30, 2020

Recall Summary

Recall Number D-0135-2021
Classification Class II — Moderate risk
Date Initiated November 30, 2020
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Advanced Nutriceuticals, LLC
Location Indianapolis, IN
Product Type Drugs
Quantity 1 vial

Product Description

GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Reason for Recall

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Distribution Pattern

CA, CO, FL, IN, KY, OH, TX

Lot / Code Information

Lot #1112202008, Exp 12/11/2020

Other Recalls from Advanced Nutriceuticals, LLC

Recall # Classification Product Date
D-0132-2021 Class II BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Inst... Nov 30, 2020
D-0133-2021 Class II THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guy... Nov 30, 2020
D-0143-2021 Class II LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Instit... Nov 30, 2020
D-0131-2021 Class II AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Inst... Nov 30, 2020
D-0139-2021 Class II CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guye... Nov 30, 2020

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.