Lyne Laboratories Recalls Subpotent Fluocinolone Acetonide Ear Drops
Lyne Laboratories is recalling 17,939 units of Fluocinolone Acetonide Topical Oil ear drops because the medication is subpotent.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a subpotent drug, which is a minor labeling or potency error without reported injuries or hospitalizations, fitting the Moderate severity criteria.
Plain-English summary
Lyne Laboratories, Inc. is voluntarily recalling 17,939 units of Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops), 20 mL. The product is a prescription-only medication manufactured by Lyne Laboratories in Brockton, Massachusetts, for Rising Pharmaceuticals, Inc. in Allendale, New Jersey.
The recall was initiated because the drug is subpotent, meaning it does not contain the full amount of the active ingredient required. The affected lots are FR1604B, FR1604C, and FR 1604D, all with an expiration date of 06/2018. The product is identified by NDC 64980-329-20 and UPC 364980329200.
The FDA classified this recall as Class II, which indicates a situation that might cause temporary or medically reversible adverse health consequences. The recall was initiated on April 13, 2018, and was terminated on May 16, 2019. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for guidance.
The recalled product
- Product
- FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
- Brand
- FLUOCINOLONE ACETONIDE
- Manufacturer
- Lyne Laboratories, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 17,939
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#: FR1604B
- FR1604C
- FR 1604D
- Exp. 06/2018
UPCs (2)
- 0364980329200
- 364980329200
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Lyne Laboratories, Inc. 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 3 products in this recall →Related recalls
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