PlainRecordsFDA · Drug recall
Fluticasone propionate Nasal Spray…
- Date
- June 13, 2018
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): 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)
- Status
- Terminated
- Filed by
- Apotex Inc.
- Product
- Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326, NDC 60505-0829-1
- Reason
- Presence of foreign substance: glass particles
- Distribution pattern
- Nationwide
- Quantity
- Unknown
- Codes and lots
- Lot: NJ4501 Exp. 07/2020
- Recall started
- May 31, 2018
- Recall number
- D-0841-2018
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement report, recall number D-0841-2018. The agency record governs; check it and the company before acting.