Stat Rx USA Recalls Tobramycin Ophthalmic Ointment Due to Labeling Error
Stat Rx USA is recalling 22 units of Tobramycin Ophthalmic Ointment because the labels incorrectly identify the product as an ointment instead of a solution.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a minor labeling error (mislabeling) without reported injuries.
Plain-English summary
Stat Rx USA is recalling 22 units of Tobramycin Ophthalmic Ointment, 0.3%, 5ml bottle (NDC 16590-224-05). The product is a generic for Tobrex, manufactured by Akorn, Inc. The affected lots are 06JN1265 (Exp 3/14) and 06JN1266 (Exp 4/14).
The recall was initiated due to a labeling error. The affected units were labeled incorrectly, describing the product as an "ointment" instead of a "solution." This mislabeling could lead to confusion regarding the product's formulation.
The affected units were distributed in Florida, Pennsylvania, and Virginia. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If found, the product should not be used and should be returned to the pharmacy or supplier for credit.
The recalled product
- Product
- Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05,
- Manufacturer
- Stat Rx USA
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 22
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 (1)
- Lot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14
Distribution
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