US Compounding Recalls Triamcinolone Diacetate Vials Due to Sterility Concerns
US Compounding Inc is recalling 33,778 vials of Triamcinolone diacetate USP PF (40 mg/mL) nationwide due to deficient practices that may impact sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe; while no specific injuries are reported in the text, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of harm (sepsis/infection) that aligns with the Severe tier for high-risk medical products where sterility is compromised.
Plain-English summary
US Compounding Inc is recalling 33,778 vials of Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and is distributed nationwide.
The recall is being conducted due to a lack of assurance of sterility. The firm identified deficient practices that may have an impact on sterility assurance for all sterile preparations within their expiry dates. The FDA has classified this as a Class II recall.
Patients who have received this medication should contact their healthcare provider for guidance. The specific lot codes and best-use dates for the affected vials are listed in the official recall documentation.
The recalled product
- Product
- Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3206-01
- Manufacturer
- US Compounding Inc
- Affected units
- 33,778
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Lot Code: 20150608@19 BUD: 2/2/2016
- 20150807@35 BUD: 1/4/2016
- 20152104@12 BUD: 10/1//2015
- 20150105@2 BUD: 10/28/2015
- 20150605@36 BUD: 11/2/2015
- 20150607@26 BUD: 1/2/2016
- 20150904@32 BUD: 10/6/2015
- 20150906@35 BUD: 12/6/2015
- 20151506@45 BUD: 12/12/2015
- 20151603@43 BUD: 9/12/2015
- 20152204@15 BUD: 10/19/2015
- 20152506@35 BUD: 12/22/2015
- 20152907@1 BUD: 1/25/2016
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 59 products in this recall →Related recalls
Same manufacturer · US Compounding Inc
See all →- LowUS Compounding Recalls Succinylcholine Chloride Injection Due to Labeling Error
FDA (Drugs) · 2021-01-20
- LowUS Compounding Recalls Neostigmine Methylsulfate Syringes Due to Missing Labels
FDA (Drugs) · 2021-01-06
- SevereUS Compounding Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-02-27
- ModerateUS Compounding Recalls LET Gel 4% Syringes Due to Missing Lot and Expiration Dates
FDA (Drugs) · 2019-02-20
- SevereUS Compounding Recalls Docusate Oral Syringes Due to B. cepacia Contamination
FDA (Drugs) · 2016-12-28
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- SevereFDA Recalls Triamcinolone Diacetate Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-05-01
- Severe
- SevereMontana Compounding Pharmacy Recalls Trimix Injectable Due to Sterility Concerns
FDA (Drugs) · 2015-06-17
- HighNew England Compounding Center Recalls Triamcinolone Vials Due to Sterility Concerns
FDA (Drugs) · 2013-01-09
- SevereFDA Recalls Compounded Injectable Testosterone and Anastrazole Vials for Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereMain Street Compounding Pharmacy Recalls Triamcinolone Diacetate Due to Adverse Reactions
FDA (Drugs) · 2013-12-11