Spectrum Chemical Recalls Ranitidine Hydrochloride Powder Due to NDMA Impurity
Spectrum Laboratory Products is recalling Ranitidine Hydrochloride powder due to the presence of NDMA impurity. The product was distributed to pharmacies in 11 US states and internationally.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves the presence of NDMA, a known carcinogenic impurity, which constitutes a significant health risk.
Plain-English summary
Spectrum Laboratory Products is recalling Ranitidine Hydrochloride (powder), USP, Rx only, manufactured by Spectrum Chemical Mfg Corp. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. The affected lot number is 11E0585, with an expiration date of October 2023.
The recalled active pharmaceutical ingredient (API) was distributed to pharmacies in Arizona, California, Florida, Georgia, New Jersey, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, and Wyoming. The API was also distributed internationally to Canada and the United Arab Emirates. The product is available in 1 gram, 5 grams, 25 grams, 100 grams, 500 grams, and 1 kilogram quantities.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- 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 Kilogram
- Manufacturer
- Spectrum Laboratory Products
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #:11E0585
- Exp. October 2023
Distribution
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