Why it was recalled
CGMP Deviations: Received notice from supplier that there is potential glass contamination.
Product description
Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
Lot numbers, UPCs & expiration codes
Lot # 1HE0899, 1IB0005, Exp 02/28/2023
Where it was sold
Product was distributed to compounding pharmacies and labs in CA, CO, MD, SC.
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-0141-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 12, 2019
- FDA report date
- Oct 23, 2019
- Quantity
- 29.1 grams
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Spectrum Laboratory Products
Original FDA data
Every field from FDA enforcement report D-0141-2020, exactly as published.
Show all FDA fields
- City
- Gardena
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 83796
- Address
- 14422 S San Pedro St
- Code information
- Lot # 1HE0899, 1IB0005, Exp 02/28/2023
- Postal code
- 90248-2027
- Report date
- Oct 23, 2019
- Product type
- Drugs
- Recall number
- D-0141-2020
- Classification
- Class II
- Recalling firm
- Spectrum Laboratory Products
- Product quantity
- 29.1 grams
- Termination date
- Nov 10, 2020
- Reason for recall
- CGMP Deviations: Received notice from supplier that there is potential glass contamination.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
- Distribution pattern
- Product was distributed to compounding pharmacies and labs in CA, CO, MD, SC.
- Recall initiation date
- Sep 12, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 15, 2019