CLASS II Drug recall · Reported 25 Apr 2018 · FDA Enforcement Report
Lipoic Acid 25mg/mL amber vial recalled by Partell Specialty Pharmacy
Partell Specialty Pharmacy is recalling Lipoic Acid 25mg/mL amber vial, distributed in Nevada. The recall was initiated on 22 Mar 2018 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-0640-2018
- FDA event ID
- 79619
- Recalling firm
- Partell Specialty Pharmacy, Las Vegas, NV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Mar 2018
- FDA classified
- 17 Apr 2018
- Reported
- 25 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 22 Mar 2018 | Recall initiated by company | |
| 17 Apr 2018 | Classified by FDA | +26 days |
| 25 Apr 2018 | 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 Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
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
Lipoic Acid 25mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Where it was distributed
NV only
Questions about this recall
Is Lipoic Acid 25mg/mL amber vial recalled?
Yes. Partell Specialty Pharmacy recalled Lipoic Acid 25mg/mL amber vial on 22 Mar 2018. The recall is Class II and its status is Terminated. Recall number D-0640-2018.
Why was it recalled?
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Which lots are affected?
Lot#: 20180124@10, BUD 04/05/2018; 20180220@9, BUD 05/21/2018; 20180102@33, BUD 04/02/2018.
Where was it sold?
NV only
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.