Class I · High risk
Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I
Non-Sterility; microbial contamination identified as Bacillus circulans
HCG (Chorionic Gonadotropin Lyopholized)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459
- Recalling firm
- Town and Country Compounding and Consultation Services, LLC
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0436-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Town and Country Compounding and Consultation Services, LLC
All 2016 recallsOther wrong potency / content recalls from 2016
All wrong potency / content recalls
Class III · Low risk
Aripiprazole Tablets
Superpotent Drug; out of specification results for assay (manufacturer)
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Subpotency: due to a low, out of specification test result for assay during stability testing.
Class III · Low risk
Aripiprazole Tablets
Superpotent Drug: Product may not meet specifications throughout shelf life.
Class III · Low risk
Donepezil Hydrochloride Tablets
Subpotent Drug: out of specification results for assay test.
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