Sermorelin Forte Plus 18 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 mg). Compounded by Tri...

FDA Drug Recall #D-0292-2017 — Class II — November 17, 2016

Recall Summary

Recall Number D-0292-2017
Classification Class II — Moderate risk
Date Initiated November 17, 2016
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Tri-Coast Pharmacy
Location Juno Beach, FL
Product Type Drugs
Quantity 441 vials

Product Description

Sermorelin Forte Plus 18 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 mg). Compounded by Tri-Coast Pharmacy

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide

Lot / Code Information

Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05252016C (11/21/2016), 07252016B (01/21/2017), 09192016B (03/18/2016).

Other Recalls from Tri-Coast Pharmacy

Recall # Classification Product Date
D-0318-2017 Class II TriMix, Alprostadil/Phentolamine/Papaverine 40m... Nov 17, 2016
D-0307-2017 Class II Testosterone Propionate 100 mg/mL, (5 ML). Com... Nov 17, 2016
D-0270-2017 Class II Lipotropic (L-Carnitine 170 mg + Methylcobalami... Nov 17, 2016
D-0321-2017 Class II Ultra Amino Blend (Arginine HCL 105 mg + Lysine... Nov 17, 2016
D-0322-2017 Class II Ultra Amino Energy Cocktail (Methionine (L) 12.... Nov 17, 2016

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.