FDA Recall D-0323-2017

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

Ultra Cocktail #2 (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 170mg/Thiamine HCL 20mg/Riboflavin-5-Phosphate Sod 2mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 20mg/Chromium Picolinate 66mcg/Lidocaine HCL 10mg/mL), (30 ML and 10 ML). Compounded by Tri-Coast Pharmacy

Lot / code: Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05192016A (11/15/2016), 08032016B (12/31/2016), 08232016A (12/31/2016), 09292016C (01/31/2017).

Quantity: 123 vials

Reason for recall

Lack of Assurance of Sterility

Recall record

Recall number: D-0323-2017
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.

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