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Class II: temporary or reversible health riskTerminated

Nephron Pharmaceuticals Asthmanefrin Racepinephrine Inhalation Recall

Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepineph…

Nephron Pharmaceuticals Corp. · Orlando, FL

Risk level
Class II
Reported by FDA
Dec 9, 2015
Recall ID
D-0388-2016
Check your lot numberHow we source this data

Summary

Nephron Pharmaceuticals recalled Asthmanefrin Racepinephrine Inhalation starting Aug 21, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0388-2016 on Dec 9, 2015. Reason: Discoloration. Status: Terminated.

Why it was recalled

Discoloration

Product description

Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with 1 EZ Breathe Atomizer per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-10

Lot numbers, UPCs & expiration codes

Lots R4027A (Exp 10/31/2015), R4036A (Exp 12/31/2015)

Where it was sold

Nationwide

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-0388-2016
Classification
Class II
Status
Terminated
Recall initiated
Aug 21, 2015
FDA report date
Dec 9, 2015
Quantity
47,754 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Nephron Pharmaceuticals Corp.

Original FDA data

Every field from FDA enforcement report D-0388-2016, exactly as published.

Show all FDA fields
City
Orlando
State
FL
Status
Terminated
Country
United States
Event ID
72102
Address
4121 SW 34th St
Code information
Lots R4027A (Exp 10/31/2015), R4036A (Exp 12/31/2015)
Postal code
32811-6475
Report date
Dec 9, 2015
Product type
Drugs
Recall number
D-0388-2016
Classification
Class II
Recalling firm
Nephron Pharmaceuticals Corp.
Product quantity
47,754 cartons
Termination date
Feb 10, 2017
Reason for recall
Discoloration
Voluntary / mandated
Voluntary: Firm initiated
Product description
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with 1 EZ Breathe Atomizer per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-10
Distribution pattern
Nationwide
Recall initiation date
Aug 21, 2015
Initial firm notification
E-Mail
Center classification date
Nov 27, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0388-2016, published Dec 9, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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