Red Mountain Compounding Recalls S-Amitriptyline Injection Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Amitriptyline 10mg/mL injection vials because the FDA determined there is a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as infection from non-sterile injections) are rated as Severe (4), especially given the lack of assurance of sterility for an injectable drug.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Amitriptyline 10mg/mL multi-dose vial injection solution. The recall involves 30 mL glass vials, with a quantity of 2 vials per unit. The specific lot number is S06272019DT@08, and the best before date is September 27, 2019.
The recall was initiated due to a lack of assurance of sterility. This means the product may not be sterile, which poses a risk of infection if administered. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The product was distributed nationwide in the USA. Patients who have received this medication should contact their healthcare provider for guidance. Consumers should not use the recalled product and should return it to the pharmacy or contact the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX
- Category
- Drug — Injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: S06272019DT@08
- BUD: 9/27/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 100 products in this recall →Related recalls
Same manufacturer · First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
See all →- SevereMIT/B12 Compounded Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
- HighTestosterone Ultra 250MG/ML Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
- SevereRed Mountain Compounding Test Cypionate Sterility Assurance Recall
FDA (Drugs) · 2021-11-03
- SevereTEST CYP/PROP Compounded Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
- HighTEST CYP 25MG/ML Injectable Lacks Assurance of Sterility
FDA (Drugs) · 2021-11-03
Same hazard · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15