Class II · Moderate risk
Zilretta (triamcinolone acetonide extended-release injectable suspension)
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
Exparel (Bupivacaine)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Sub Potent Drug: Out of Specification (OOS)
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial, Rx only, Manufactured by: Pacira Pharmaceuticals, Inc. San Diego, CA 92121. NDC: 65250-266-20,
Affected NDC
65250-0266-20
Compare with the code on your package — it is the most precise check available.
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 |
|---|---|---|---|---|
| Exparel bupivacaine NDC 65250-0266 |
13.3 mg/mL | Injection, Suspension, Liposomal Infiltration |
Pacira Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Pacira Pharmaceuticals, Inc.
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0621-2020 · 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Pacira Pharmaceuticals, Inc.
All 2019 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 (bupivacaine liposome injectable suspension)
Subpotent; bupivacaine
Other wrong potency / content recalls from 2019
All wrong potency / content recalls
Class III · Low risk
PCA Skin Blemish Control Bar
Superpotent Drug: Salicylic acid content is above the firm's specification.
Class II · Moderate risk
Hydrocortisone and Acetic Acid Otic Solution
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Class III · Low risk
Class III · Low risk
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