CLASS II Drug recall · Reported 15 Oct 2014 · FDA Enforcement Report
All sterile products within expiry recalled by Unique Pharmaceutical
Unique Pharmaceutical is recalling All sterile products within expiry, distributed nationwide in the US. The recall was initiated on 18 Jul 2014 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-0012-2015
- FDA event ID
- 68841
- Recalling firm
- Unique Pharmaceutical, Temple, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jul 2014
- FDA classified
- 9 Oct 2014
- Reported
- 15 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
Timeline
| 18 Jul 2014 | Recall initiated by company | |
| 9 Oct 2014 | Classified by FDA | +83 days |
| 15 Oct 2014 | Published in enforcement report | +6 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 Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
All sterile products within expiry
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.
Which lots are affected?
All Lots
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 68841| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | N-Acetyl Cysteine 20% Vial Stock recalled by Unique Pharmaceutical | Unique Pharmaceutical | Sterility | Nationwide |
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 | NORepinephrine 4 mg in Sodium Chloride0.9%, For IV Use Only recalled | Unique Pharmaceutical | Mold | PA, TN, TX |