D-0255-2017 Class II Ongoing
FDA drug recall D-0255-2017 was initiated by Tri-Coast Pharmacy on Nov 17, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 10 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 11, 2017
- Initiation Date
- Nov 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 vials
Product Description
Calm Me (Aminobutyric Acid (GABA) 50 mg/Magnesium Chloride 50 mg/Taurine 50 mg/Theanine (L) 50 mg/Tryptophan (L) 10 mg/Lidocaine HCL 10 mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide
Code Information
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 09212016A (01/31/2017), 08032016C (01/31/2017).
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0255-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026