Lyne Laboratories Recalls Subpotent Fluocinolone Acetonide Topical Oil
Lyne Laboratories is recalling 12,572 units of Fluocinolone Acetonide Topical Oil because the product is subpotent. The recall is voluntary and was initiated by the firm.
What this means for you
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, which the rubric associates with moderate severity when no hospitalizations or serious injuries are reported. The hazard is a subpotent drug, which is a quality issue rather than a direct physical injury risk like choking or fire.
Plain-English summary
Lyne Laboratories, Inc. is voluntarily recalling 12,572 units of Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil), 118.28 mL (4 fl. oz.). The product is a prescription-only topical corticosteroid manufactured by Lyne Laboratories, Inc. in Brockton, MA, for Rising Pharmaceuticals, Inc. in Allendale, NJ. The specific NDC is 64980-331-04 and the UPC is 364980331043.
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 affected lots are FR1603 and FR1604A, both with an expiration date of 05/2018. The recall was initiated on April 13, 2018, and was classified as Class II by the FDA.
The distribution pattern for these units is listed as 'to be entered' in the source data. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If found, the product should be returned to the pharmacy or supplier for disposal or credit, as directed by the recalling firm.
The recalled product
- Product
- FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
- Brand
- FLUOCINOLONE ACETONIDE
- Manufacturer
- Lyne Laboratories, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 12,572
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 #: FR1603
- FR1604A
- Exp. 05/2018
UPCs (1)
- 364980331043
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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