CLASS II Drug recall · Reported 5 Oct 2016 · FDA Enforcement Report

Brilliant Blue G (BBG) 025% SDV, Rx, Vital Care Compounder recalled

Pharmacy Plus is recalling Brilliant Blue G (BBG) 025% SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402, distributed in Mississippi. The recall was initiated on 26 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot# 396817, Use by 09/13/16
Quantity recalled14 vials

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-1537-2016
FDA event ID
75164
Recalling firm
Pharmacy Plus, Hattiesburg, MS
Classification
Class II
Status
Terminated
Recall initiated
26 Jul 2016
FDA classified
27 Sep 2016
Reported
5 Oct 2016
Type
Voluntary: Firm initiated
Customers notified by
Telephone
Reason category
Sterility

Timeline

26 Jul 2016Recall initiated by company
27 Sep 2016Classified by FDA+63 days
5 Oct 2016Published 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 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

Brilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402

Where it was distributed

MS

Mississippi

Questions about this recall

Is Brilliant Blue G (BBG) 025% SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402 recalled?

Yes. Pharmacy Plus recalled Brilliant Blue G (BBG) 025% SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402 on 26 Jul 2016. The recall is Class II and its status is Terminated. Recall number D-1537-2016.

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lot# 396817, Use by 09/13/16

Where was it sold?

MS

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.

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