D-1220-2016 Class II Terminated
FDA drug recall D-1220-2016 was initiated by Medaus, Inc. on May 13, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Jun 16, 2017). Affected quantity: 187 mL in Vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 20, 2016
- Initiation Date
- May 13, 2016
- Termination Date
- Jun 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 187 mL in Vials
Product Description
M.I.C. 25/50/50 (PF) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50MG/ML, In 2ML Vials, MEDAUS PHARMACY
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S. Nationwide, Japan, and New Zealand.
Code Information
Lot #: 151130-48, BUD: 05/26/16; Lot #: 151215-7, BUD: 05/26/16; Lot #: 151216-12, BUD: 05/26/16; Lot #: 160106-27, BUD: 05/26/16; Lot #: 160113-38, BUD: 07/11/16; Lot #: 160223-33, BUD: 07/31/16; Lot #: 160307-36, BUD: 07/31/16; Lot #: 160307-52, BUD: 07/31/16; Lot #: 160308-5, BUD: 07/31/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1220-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026