CLASS II Drug recall · Reported 7 Nov 2018 · FDA Enforcement Report

Lipo MIC-12 Compound Injectable a) recalled by Pharm D Solutions

Pharm D Solutions is recalling Lipo MIC-12 Compound Injectable a), distributed nationwide in the US. The recall was initiated on 10 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: a) 09042018:66/A Discard by: 3/3/2019; 07302018:65 Discard by: 1/26/2019; b) 08132018:75/A Discard by: 2/1/2019; 04172018:16 Discard by: 9/30/2018; 03212018:27 Discard by: 9/17/2018; 04242018:82 Discard by: 10/20/2018; 05142018:72 Discard by: 11/10/2018; 06192018:67 Discard by: 12/18/2018; 08142018:00 Discard by: 2/1/2019; 07302018:64 Discard by: 1/26/2019
Quantity recalled896 vials; 64000 milliliters

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-0166-2019
FDA event ID
81002
Recalling firm
Pharm D Solutions, Houston, TX
Classification
Class II
Status
Terminated
Recall initiated
10 Sep 2018
FDA classified
1 Nov 2018
Reported
7 Nov 2018
Type
Voluntary: Firm initiated
Customers notified by
Press Release
Reason category
Sterility

Timeline

10 Sep 2018Recall initiated by company
1 Nov 2018Classified by FDA+52 days
7 Nov 2018Published 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 Assurance of Sterility

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

Lipo MIC-12 Compound Injectable a) NDC 69699-1603-10; b) 30 mL Stock Solution Compound Injectable NDC 69699-1603-30, Pharm D Solutions, Houston, Texas

Where it was distributed

Nationwide

Nationwide

Questions about this recall

Is Lipo MIC-12 Compound Injectable a) recalled?

Yes. Pharm D Solutions recalled Lipo MIC-12 Compound Injectable a) on 10 Sep 2018. The recall is Class II and its status is Terminated. Recall number D-0166-2019.

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lot: a) 09042018:66/A Discard by: 3/3/2019; 07302018:65 Discard by: 1/26/2019; b) 08132018:75/A Discard by: 2/1/2019; 04172018:16 Discard by: 9/30/2018; 03212018:27 Discard by: 9/17/2018; 04242018:82 Discard by: 10/20/2018; 05142018:72 Discard by: 11/10/2018; 06192018:67 Discard by: 12/18/2018; 08142018:00 Discard by: 2/1/2019; 07302018:64 Discard by: 1/26/2019

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 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.

More recalls from Pharm D Solutions

All 100