Recalls / Class II
Class IID-0712-2018
Product
Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-329-20, UPC 364980329200
- Brand name
- Fluocinolone Acetonide
- Generic name
- Fluocinolone Acetonide
- Active ingredient
- Fluocinolone Acetonide
- Route
- Auricular (otic)
- NDC
- 64980-329
- FDA application
- ANDA203378
- Affected lot / code info
- Lot#: FR1604B, FR1604C, FR 1604D, Exp. 06/2018
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Lyne Laboratories, Inc.
- Manufacturer
- Rising Pharma Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10 Burke Dr, N/A, Brockton, Massachusetts 02301-5505
Distribution
- Quantity
- 17939 units
- Distribution pattern
- to be entered
Timeline
- Recall initiated
- 2018-04-13
- FDA classified
- 2018-05-04
- Posted by FDA
- 2018-05-02
- Terminated
- 2019-05-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0712-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.