Lyne Laboratories Recalls Subpotent Fluocinolone Acetonide Topical Oil
Lyne Laboratories is recalling 23,453 units of Fluocinolone Acetonide Topical Oil because the product is subpotent. The recall is voluntary and classified as FDA Class II.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a subpotent drug, which is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Lyne Laboratories, Inc. is voluntarily recalling 23,453 units of Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil), 118.28 mL (4 fl.oz.). The product is a prescription-only medication manufactured by Lyne Laboratories, Inc. in Brockton, MA, and manufactured for Rising Pharmaceuticals, Inc. in Allendale, NJ. The affected lots are FR1601 and FR1602, with an expiration date of 05/2018. The NDC is 64980-330-04 and the UPC is 364980330046.
The reason for the recall is that the drug is subpotent, meaning it does not contain the full amount of the active ingredient required by the label. The recall was initiated by the firm on April 13, 2018, and was classified as FDA Class II. The recall status is currently terminated, with a termination date of May 16, 2019.
Consumers and healthcare providers should discontinue use of the affected product. The source text does not specify the distribution pattern or the specific geographic areas where the product was sold. No illnesses or injuries are reported in the source text.
The recalled product
- Product
- FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
- Brand
- FLUOCINOLONE ACETONIDE
- Manufacturer
- Lyne Laboratories, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 23,453
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 (3)
- Lot #: FR1601
- FR1602
- Exp. 05/2018
UPCs (1)
- 364980330046
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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