Spectrum Laboratory Products, Inc. has issued a voluntary recall of its Epinephrine (L-Adrenaline) USP Bulk Active Pharmaceutical Ingredient (API), Lot number LP5003, Expiration date 12/2020, due to the product being discolored. The user-level recall was initiated after consumer complaints of the products being discolored.
Risk Statement
Epinephrine is used to treat critical life-threatening conditions that can occur to an individual at any age. These conditions include severe allergic reactions (anaphylaxis), certain cardiac conditions such as severe chest pain, severe asthma, and very low blood sugar in diabetes.
The use of this recalled product can cause ineffective treatment of the conditions listed, which can lead to worsening symptoms and hospitalizations.
A less effective product or underdosing epinephrine could lead to death. To date, Spectrum Laboratory Products, Inc. has not received any reports of adverse events related to this recall.
Epinephrine (L-Adrenaline) USP bulk API Powder is used to manufacture, or compound finished dosage forms of epinephrine prescription products.
They are used for the treatment of life-threatening conditions such as anaphylaxis and other severe hypersensitivity reactions such as nose congestion, hypersensitivity, asthma, bronchospasm, heart failure, hypertension, sudden cardiac arrest, shock, bradycardia, or atrioventricular block.
Consumers can identify the Epinephrine (L-Adrenaline) USP bulk API Powder with their amber glass bottles and vacuum-sealed pouch enclosure. Consumers can identify the Epinephrine, USP product with their Spectrum catalog number EP130.
The products were distributed to all Spectrum facilities nationwide in Canada and USA. The details about the lot numbers, package size, and expiration date are listed in the table below.
| Product | NDC | Package Size | Lot # | Exp Date |
|---|---|---|---|---|
| Epinephrine, USP (Product code EP130) | ||||
| 49452-2740-2 | 1 KG | 1KG0865 | 31-Mar-2023 | |
| 49452-2740-1 | 100 GM | |||
| 49452-2740-4 | 1 GM | 2KL0353 | 30-Sep-2023 | |
| 49452-2740-3 | 25 GM | 2KF0151 | 31-Mar-2023 | |
| 49452-2740-5 | 5 GM |
Spectrum Laboratory Products, Inc. is notifying distributors directly by telephone and email to arrange for the return of all recalled products.
Distributors should immediately cease distribution and quarantine any existing inventory and products distributed from this lot.
Consumers should immediately discontinue the use of the product and contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Consumers with questions regarding the recall can email Spectrum Laboratory Products, Inc. at [email protected] or call 800-772-8786 Monday to Friday from 8 am to 5 pm, pacific time.
Consumers are advised to consult their healthcare providers if they have experienced any problems that may be related to taking or using this drug product.
Adverse Reactions or quality issues can be reported to FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. The address and website are listed below:
- Website: https://www.fda.gov/medwatch
- Regular Mail: use postage-paid FDA form 3500 available at https://www.fda.gov/MedWatch/getforms.htm
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
