Red Mountain Compounding Pharmacy Recalls Gentamicin Irrigation Solution Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Gentamicin 480mg/1L irrigation solution because the product lacks assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Gentamicin 480mg/1L irrigation solution in 1000ml plastic bottles. The recall was initiated because the product lacks assurance of sterility.
The affected product includes two 1-liter bottles with the following lot numbers and expiration dates: S07092019DT@18 (Exp 8/23/19) and S07312019DH@08 (Exp 10/14/19). The product was distributed nationwide in the USA.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- S-GENTAMICIN 480MG/1L, IRRIGATION SOLN, 1000ML plastic bottle, Red Mountain Compounding Pharmacy
- Hazard
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 (4)
- Lot #: S07092019DT@18
- Exp 8/23/19
- S07312019DH@08
- Exp 10/14/19
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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