Red Mountain Compounding Recalls Ophthalmic Gel Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling a specific lot of ophthalmic gel because the FDA determined there is a lack of 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. According to the rubric, FDA Class II recalls with potential for significant injury or property damage, or those involving high-risk pathogens/sterility issues where hospitalization is a potential consequence, are rated as Severe (4).
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-GAT/KLAC/LIDO/PHE/TPMD 0.036/0.036/1.42/0.71/0.071%, OPTH GEL, 5ML dropper bottle. The recall is limited to Lot # S07292019DH@08 with an expiration date of 9/29/19.
The FDA has classified this recall as Class II, citing a lack of assurance of sterility. This means there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible health consequences.
The product was distributed nationwide in the USA. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be discontinued and returned to the pharmacy or disposed of according to local regulations.
The recalled product
- Product
- S-GAT/KLAC/LIDO/PHE/TPMD 0.036/0.036/1.42/0.71/0.071%, OPTH GEL, 5ML dropper bottle, Red Mountain Compounding RX.
- Category
- Drug — Compounded Ophthalmic
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 #: S07292019DH@08
- Exp 9/29/19
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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