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.