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ForumsVerified VendorsSwiss Chems got an FDA warning letter — January 2024

Swiss Chems got an FDA warning letter — January 2024

bbq_ray_KC Thu, May 9, 2024 at 12:38 PM 11 replies 1,821 viewsPage 1 of 3
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bbq_ray_KC
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Jul 2024
Kansas City, KS
May 9, 2024 at 2:03 PM#1

⚠️ QUALITY ALERT ⚠️

I sent a vial of compounded semaglutide (Lot# SEM-2026-0287) to an independent lab for full panel testing. Identity and potency came back fine (97.4% — no complaints there). But the endotoxin test came back POSITIVE.

LAL (Limulus Amebocyte Lysate) test result: 8.2 EU/mL

The USP limit for injectable products is 5 EU/kg/hr, and most compounding pharmacies use a limit of ≤0.5 EU/mL for their products.

My result is 16x over the typical limit. I've been using this vial for 2 weeks.

I'm freaking out. What are the health implications? Has anyone else had this experience? I've already reported this to the pharmacy and my state board. I'm naming the pharmacy in this post because I think people need to know — it's [REDACTED BY MOD].

16 2COA_Karl, MikeFit_NJ, InsuranceTom and 13 others
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mike_mealprep
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Jul 2024
Chicago, IL
May 9, 2024 at 2:20 PM#2

Andy, I've redacted the pharmacy name per forum rules — we can't allow naming without verified documentation. Please send the lab report to mod mail and we'll review. If verified, we'll allow the name to be posted. This protects both the community and the forum from liability.

That said, this is a serious report and I'm escalating it internally. 🔴

20 6newstart_MO, mia_MS2, LeilaHI and 17 others
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GenomicsKate
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Oct 2024
Cambridge, MA
May 9, 2024 at 2:37 PM#3

Andy — first, take a breath. Let me explain what this means clinically.

Endotoxins are lipopolysaccharides (LPS) from gram-negative bacterial cell walls. They can cause:

  • Fever (pyrogenic reaction)
  • Chills, body aches
  • In severe cases: sepsis, organ dysfunction

However, the risk depends on the dose delivered and your body's response. At 8.2 EU/mL with a small injection volume (say 0.1-0.2mL for a typical sema dose), your actual endotoxin exposure per injection was roughly 0.8-1.6 EU. For a 70kg person, the USP limit is 350 EU/hr (5 EU/kg × 70kg). So you were well under the systemic toxicity threshold.

That doesn't make it OK — the product fails specifications and shouldn't have been released. But you're likely not in medical danger from what you've already injected.

STOP using this vial immediately. If you develop fever, chills, or signs of infection at the injection site, go to the ER and tell them about the endotoxin exposure.

Last edited: May 9, 2024 at 7:37 PM
20 11MarkLI_maint, Dr.PeteFamMed, claudia_zurich and 17 others
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WendyG_ATL
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Apr 2024
Georgia
May 9, 2024 at 2:54 PM#4

Thank you for running those numbers. That math actually makes me feel a lot better. I haven't had any fever or unusual symptoms beyond normal sema side effects. Stopped using the vial immediately when I got the results.

I've sent the full lab report to mod mail. Happy to have the pharmacy name posted once verified. People need to know.

Last edited: May 9, 2024 at 3:54 PM
8 1AttorneyGrant, DebRD_ATL, KristenIndy and 5 others
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hans_munich
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Jul 2024
Munich, DE
May 9, 2024 at 3:11 PM#5

Former QC lab director weighing in. An endotoxin result of 8.2 EU/mL indicates a fundamental failure in sterile manufacturing processes. Endotoxins come from gram-negative bacteria, which means at some point in the production chain, bacterial contamination occurred. Even if the bacteria were killed during filtration/sterilization, endotoxins are incredibly heat-stable and difficult to remove.

This could indicate:

  • Contaminated raw materials (API or water)
  • Inadequate depyrogenation of glassware
  • WFI (Water for Injection) system failure
  • Environmental monitoring failures in the cleanroom

If one batch has this issue, others from the same facility likely do too. This is a systemic problem, not a one-off.

12 21emma_london, tammy_FL, Dr.LipidDallas and 9 others
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