NDC 84549-159
Adrenalin 1 mg per 1 mL injection
On the label: ProPharma Distribution. It's repackaged: ProPharma Distribution rebottles it from ENDO USA, Inc.'s NDC 42023-159.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Par Health USA, LLC | Rochester, MI, United States | Makes it | Serious problems, FDA actionOct 20, 2025 · 13 inspections, 1 with FDA action |
| Par Sterile Products LLC | Parsippany, New Jersey, United States | Makes it | No problems foundMar 11, 2014 · 2 inspections |
Repackaging site
- ProPharma Distribution, Westminster, CO, United States · repackages it and relabels it
Recalls
- Jan 17, 2024 · Class II · Henry Schein Inc. and Glove Club HSI Gloves Inc.
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Lots: Original Lot # 64103, exp. date 11/24 Repackaged Lot # 39747, exp. date 01/26 - Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Epinephrine: every company that makes it
- Form
- injection, intramuscular; intravenous; subcutaneous
- Strength
- 1 mg per 1 mL
- Approval
- NDA NDA204200
- On the market since
- Jul 1, 2013
- Package NDCs
84549-159-25- Official label
- DailyMed (National Library of Medicine), updated Dec 18, 2025
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