CLASS II Drug recall · Reported 24 Sep 2014 · FDA Enforcement Report
NORepinephrine 4 mg in Sodium Chloride0.9%, For IV Use Only recalled
Unique Pharmaceutical is recalling NORepinephrine 4 mg in Sodium Chloride0.9%, For IV Use Only, Flexible, distributed in Pennsylvania, Tennessee, Texas. The recall was initiated on 17 Apr 2013 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-1587-2014
- FDA event ID
- 67904
- Recalling firm
- Unique Pharmaceutical, Temple, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Apr 2013
- FDA classified
- 16 Sep 2014
- Reported
- 24 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
- Drug class
- Allergy Medication
Timeline
| 17 Apr 2013 | Recall initiated by company | |
| 16 Sep 2014 | Classified by FDA | +517 days |
| 24 Sep 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production.
Product as listed by the FDA
NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502
Where it was distributed
TN, PA, and TX
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production.
Which lots are affected?
Lot # 00083844 Exp. 07/13
Where was it sold?
TN, PA, and TX
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.
More recalls from Unique Pharmaceutical
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | N-Acetyl Cysteine 20% Vial Stock recalled by Unique Pharmaceutical | Unique Pharmaceutical | Sterility | Nationwide |
| Drug | CLASS II | All sterile products within expiry recalled by Unique Pharmaceutical | Unique Pharmaceutical | Sterility | Nationwide |
Other Norepinephrine recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | NORepinephrine 4 mg/ added to 0.9% sodium chloride 16 mcg/mL, IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | norepinephrine, 16 mg, added to dextrose 5%, IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine 8mg in 0.9% Sodium Chloride recalled | SCA Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Norepinephrine in 5% Dextrose Injection, 8 mg recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine, 4 mg per, (18 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |