Ranitidine Hydrochloride recall: Nitrosamine Impurity
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…
Why was Ranitidine Hydrochloride recalled?
CGMP Deviations: Presence of NDMA impurity detected in product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #:11E0585, Exp. October 2023
- Product
- 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…
- Recalling firm
- Spectrum Laboratory Products
- Quantity
- N/A
- Distribution
- 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.
- Recall date
- February 12, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)