FDA Recall D-0260-2017
Tri-Coast Pharmacy · Juno Beach, FL
Class II Ongoing 3465 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Glutathione 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
Reason for recall
Lack of Assurance of Sterility
Recall record
- Recall number
D-0260-2017- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide
- Recall initiated
- 2016-11-17
- Classified by FDA Center
- 2017-01-04
- FDA published
- 2017-01-11
- Recalling firm
- Tri-Coast Pharmacy
- Firm location
- Juno Beach, FL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.