D-0636-2018 Class II Terminated
FDA drug recall D-0636-2018 was initiated by Partell Specialty Pharmacy on Mar 22, 2018 and is designated Class II. Reason for recall: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. The recall status is terminated (terminated Jan 15, 2019). Affected quantity: 2 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 25, 2018
- Initiation Date
- Mar 22, 2018
- Termination Date
- Jan 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 vials
Product Description
Biotin Suspension 10mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Distribution Pattern
NV only
Code Information
Lot #:20180216@10, BUD 5/17/2018; 20180129@25, BUD 04/29/2018.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0636-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026