CLASS II Drug recall · Reported 9 Dec 2015 · FDA Enforcement Report
Asthmanefrin Racepinephrine Inhalation Solution recalled
Nephron Pharmaceuticals is recalling Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Racepinephrine, distributed nationwide in the US. The recall was initiated on 21 Aug 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0389-2016
- FDA event ID
- 72102
- Recalling firm
- Nephron Pharmaceuticals, Orlando, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Aug 2015
- FDA classified
- 27 Nov 2015
- Reported
- 9 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Drug class
- Allergy Medication
Timeline
| 21 Aug 2015 | Recall initiated by company | |
| 27 Nov 2015 | Classified by FDA | +98 days |
| 9 Dec 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration
Product as listed by the FDA
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Racepinephrine USP 11.25 mg), 30 individual foil wrapped vials per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Discoloration
Which lots are affected?
Lots R4016A (Exp 08/31/2015), R4017A (Exp 08/31/2015), R4035A (Exp 12/31/2015)
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 72102This product is part of a recall event; the main page for the event is Asthmanefrin Racepinephrine Inhalation Solution recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Asthmanefrin Racepinephrine Inhalation Solution recalled | Nephron Pharmaceuticals | Other | Nationwide |
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