Red Mountain Compounding Recalls Testosterone Cypionate Vials Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling specific lots of Testosterone Cypionate 200mg/mL vials because the FDA identified 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling specific lots of S-TESTOSTERONE CYP 200MG/ML MDV In SESAME OIL. The product is available in 5ml, 10ml, and 13ml glass vials and is prescription-only. The recall is being conducted due to a lack of assurance of sterility.
The affected product was distributed nationwide in the USA. The recall covers 129 vials across multiple specific lot numbers, including S02252019DH@07, S03202019DT@02, and S07262019DH@06, among others. The expiration dates for these lots range from 8/25/19 to 1/26/20.
Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be stopped and returned to the pharmacy or manufacturer for disposal or credit.
The recalled product
- Product
- S-TESTOSTERONE CYP 200MG/ML MDV In SESAME OIL, Rx Only, a) 5ML, b) 10ML, c) 13 ML glass vial, Red Mountain Compounding Rx
- Category
- Drug — Injectable Steroids
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 (20)
- Lot #: S02252019DH@07
- Exp 8/25/19
- S03202019DT@02
- EXP
- 8/25/19
- S03212019DT@02
- 9/21/19
- S04232019DT@06
- 10/23/19
- S05232019DT@06
- 11/23/19
- S05152019DH@12
- 11/15/19
- S05242019DT@03
- 11/24/19
- 05152019DH@12
- S06262019DT@02
- 12/26/19
- S07032019DT@12
- 1/3/20
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.
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