Why it was recalled
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Product description
Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)1 G, (c) 25 G, (d) 5 G; Rx only. Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901.
Lot numbers, UPCs & expiration codes
Lot # (a) (b) (c) (d) lot 2KL0353, EXP 30-Sep-2023; 2KF0151, EXP 31-Mar-2023
Where it was sold
Nationwide in the USA, Puerto Rico and Canada
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-0180-2023
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 19, 2022
- FDA report date
- Feb 1, 2023
- Quantity
- 7 x 100G; 17 x 1G; 6 x 25G; 20 x 5G
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Spectrum Laboratory Products, Inc.
Original FDA data
Every field from FDA enforcement report D-0180-2023, exactly as published.
Show all FDA fields
- City
- New Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 91381
- Address
- 755, 769 And 777 Jersey Ave
- Code information
- Lot # (a) (b) (c) (d) lot 2KL0353, EXP 30-Sep-2023; 2KF0151, EXP 31-Mar-2023
- Postal code
- 08901-3605
- Report date
- Feb 1, 2023
- Product type
- Drugs
- Recall number
- D-0180-2023
- Classification
- Class I
- Recalling firm
- Spectrum Laboratory Products, Inc.
- Product quantity
- 7 x 100G; 17 x 1G; 6 x 25G; 20 x 5G
- Termination date
- Aug 19, 2025
- Reason for recall
- Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)1 G, (c) 25 G, (d) 5 G; Rx only. Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901.
- Distribution pattern
- Nationwide in the USA, Puerto Rico and Canada
- Recall initiation date
- Dec 19, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 25, 2023