D-0825-2020 Class II Terminated
FDA drug recall D-0825-2020 was initiated by Spectrum Laboratory Products on Jan 14, 2020 and is designated Class II. Reason for recall: CGMP Deviations: Presence of NDMA impurity detected in product. The recall status is terminated (terminated Dec 5, 2023).
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 12, 2020
- Initiation Date
- Jan 14, 2020
- Termination Date
- Dec 5, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Distribution Pattern
The recalled API was distributed to pharmacies in the following states: AZ, CA, FL, GA, NJ, PA, RI, SC, TX, UT, WY. The API was also distributed internationally to Canada and UAE.
Code Information
Lot #:11E0585, Exp. October 2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0825-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026