FDA Drug recall D-0323-2017
Ultra Cocktail #2 (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 170mg/Thiamine HCL 20mg/…
- FDA Drug
- Class II
- ongoing
- Published 2017-01-11
On 2017-01-11 the FDA classified a Class II recall of Ultra Cocktail #2 (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 170mg/Thiamine HCL 20mg/… by Tri Coast Pharmacy, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0323-2017 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2016-11-17 |
| Published | 2017-01-11 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Tri Coast Pharmacy |
| Distribution | US |
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
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05192…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). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0323-2017%22
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