Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
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
Lot numbers, UPCs & expiration codes
Lot #:11E0585, Exp. October 2023
Where it was sold
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.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0825-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 14, 2020
- FDA report date
- Feb 12, 2020
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Spectrum Laboratory Products
Original FDA data
Every field from FDA enforcement report D-0825-2020, exactly as published.
Show all FDA fields
- City
- Gardena
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 84799
- Address
- 14422 S San Pedro St
- Code information
- Lot #:11E0585, Exp. October 2023
- Postal code
- 90248-2027
- Report date
- Feb 12, 2020
- Product type
- Drugs
- Recall number
- D-0825-2020
- Classification
- Class II
- Recalling firm
- Spectrum Laboratory Products
- Termination date
- Dec 5, 2023
- Reason for recall
- CGMP Deviations: Presence of NDMA impurity detected in product.
- 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
- 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.
- Recall initiation date
- Jan 14, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 4, 2020