CLASS II Drug recall · Reported 22 Mar 2017 · FDA Enforcement Report

Triamcinolone 40 mg/mL Single-Dose Vial for Injection recalled

Isomeric Pharmacy Solution is recalling Triamcinolone 40 mg/mL Single-Dose Vial for Injection, Preservative Free, distributed nationwide in the US. The recall was initiated on 8 Mar 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #08016; Exp. 03/14/17 Lot #08018; Exp. 03/15/17 Lot #08023; Exp. 03/22/17 Lot #08026; Exp. 03/19/17 Lot #08033; Exp. 03/28/17 Lot #09004; Exp. 04/03/17 Lot #11014; Exp. 06/10/17 Lot #11031; Exp. 06/20/17

Quantity recalled6,999 single-use 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-0518-2017
FDA event ID: 76676
Recalling firm: Isomeric Pharmacy Solution, Salt Lake City, UT
Classification: Class II
Status: Terminated
Recall initiated: 8 Mar 2017
FDA classified: 13 Mar 2017
Reported: 22 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Injectable & IV Drugs

Timeline

8 Mar 2017	Recall initiated by company
13 Mar 2017	Classified by FDA	+5 days
22 Mar 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations

Product as listed by the FDA

Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only, Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, NDC 70285-1920-1

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations

Which lots are affected?

Lot #08016; Exp. 03/14/17 Lot #08018; Exp. 03/15/17 Lot #08023; Exp. 03/22/17 Lot #08026; Exp. 03/19/17 Lot #08033; Exp. 03/28/17 Lot #09004; Exp. 04/03/17 Lot #11014; Exp. 06/10/17 Lot #11031; Exp. 06/20/17

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.

Reported	Class	Recall	Company	Reason	Where
3 May 2017Drug	CLASS II	Methylprednisolone Acetate 80 mg/mL recalled	Isomeric Pharmacy Solution	Sterility	Nationwide
3 May 2017Drug	CLASS II	Phenylephrine 2.5%, Tropicamide 1% Multi-Dose Ophthalmic recalled	Isomeric Pharmacy Solution	Sterility	Nationwide
3 May 2017Drug	CLASS II	Methylprednisolone Acetate 40 mg/mL recalled	Isomeric Pharmacy Solution	Sterility	Nationwide
3 May 2017Drug	CLASS II	Triamcinolone Acetonide 40 mg/mL recalled by Isomeric Pharmacy Solution	Isomeric Pharmacy Solution	Sterility	Nationwide
3 May 2017Drug	CLASS II	Testosterone Cypionate 200 mg/mL recalled by Isomeric Pharmacy Solution	Isomeric Pharmacy Solution	Sterility	Nationwide

Other Triamcinolone recalls

All 4

Reported	Class	Recall	Company	Reason	Where
25 Nov 2015Drug	CLASS II	Triamcinolone/Lidocaine (40 mg/1%/mL) Multidose Vial recalled	US Compounding	Sterility	Nationwide
22 May 2013Drug	CLASS II	Triamcinolone Injection, all strengths recalled by FVS Holdings	FVS Holdings	Sterility	Nationwide
9 Jan 2013Drug	CLASS II	Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF recalled	New England Compounding Center	Sterility	Nationwide