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
Reported: May 2, 2018 Initiated: April 13, 2018 #D-0712-2018
Product Description
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
Reason for Recall
Subpotent Drug
Details
- Recalling Firm
- Lyne Laboratories, Inc.
- Units Affected
- 17939 units
- Distribution
- to be entered
- Location
- Brockton, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lyne Laboratories, Inc.. Units affected: 17939 units.
Why was this product recalled? ▼
Subpotent Drug
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 2, 2018. Severity: Moderate. Recall number: D-0712-2018.
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