Class II · Moderate risk
Testosterone 87.5mg
Presence of Foreign substance - potential presence of metal particulate matter
Zilretta (triamcinolone acetonide extended-release injectable suspension)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01 (carton) NDC 65250-001-01 (vial) with Diluent 5 mL Sterile single-use vial, Rx Only, Mfd. for: Pacira Pharmaceuticals, Inc. NDC 65250-002-01
Affected NDCs
65250-0001-01
65250-0002-01
65250-0003-01
Compare with the code on your package — it is the most precise check available.
Drug: Triamcinolone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Zilretta triamcinolone acetonide extended-release injectable suspension NDC 65250-0003 |
Kit Intra-Articular |
Pacira Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Pacira Pharmaceuticals INC
- NDC code
- 65250-003-01
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0567-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Triamcinolone recalls
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Class II · Moderate risk
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Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 100mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Tri-Moxi+¿
Presence of particulate matter - Glass like particles.
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide Pellet
CGMP Deviations: Potential presence of metal particulate matter
Other recalls by Pacira Pharmaceuticals INC
All 2024 recalls
Class II · Moderate risk
Drug Vial Label: Zilretta¿
Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
Class II · Moderate risk
Exparel
Sub Potent Drug: Out of Specification (OOS)
Class II · Moderate risk
EXPAREL (bupivacaine liposome injectable suspension)
Subpotent; bupivacaine
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