Epinephrine API Recalled for Discoloration and Reduced Efficacy
Spectrum Laboratory Products recalls Epinephrine (L-Adrenaline) USP in multiple lot sizes due to discoloration that could reduce the product's effectiveness. The recall affects shipments distributed nationwide in the USA, Puerto Rico, and Canada.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification establishes a minimum severity score of 4 per rubric rules. The discoloration could reduce the pharmaceutical's potency, which directly affects patient safety for this critical medication.
Plain-English summary
Spectrum Laboratory Products, Inc. is recalling Epinephrine (L-Adrenaline), USP (CAS 51-43-4), a pharmaceutical active ingredient packaged in amber glass bottles within vacuum-sealed pouches. Affected sizes include 100 G, 1 G, 25 G, and 5 G, with specific lot numbers 2KL0353 (expiration 30-Sep-2023) and 2KF0151 (expiration 31-Mar-2023).
The recall was initiated due to discoloration of the epinephrine API, which could result in reduced product potency and effectiveness. This is a Class I recall, the FDA's most serious classification.
The affected lots were distributed nationwide in the United States, Puerto Rico, and Canada.
The recalled product
- Product
- 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.
- Manufacturer
- Spectrum Laboratory Products, Inc.
- Category
- Drug
- Hazard
- discoloration
- reduced-efficacy
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 (4)
- Lot # (a) (b) (c) (d) lot 2KL0353
- EXP 30-Sep-2023
- 2KF0151
- EXP 31-Mar-2023
Distribution
Distributed nationwide across the United States.
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