Bupivacaine and Lidocaine Injection Vials Recalled for Label Mix-Up
Pfizer is recalling 163,957 vials of 0.5% Bupivacaine Hydrochloride Injection due to a label mix-up where some vials labeled as bupivacaine may contain lidocaine, and vials labeled as lidocaine may contain bupivacaine. The mix-up could lead to patients receiving the wrong local anesthetic.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: This is an FDA Class I recall of a prescription injectable drug involving a critical labeling error that could result in patients receiving the wrong anesthetic agent or concentration. While no illnesses or injuries are reported in the source text, the nature of the mix-up—where patients could receive an incorrect local anesthetic—presents serious potential for harm in a clinical setting, meeting the Class I standard and the Severe criterion.
Plain-English summary
Pfizer, Inc. is recalling 163,957 vials of 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials due to a labeling error. The affected lot is EG6023 with expiration date of 07/01/2022.
Some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may actually contain 1% Lidocaine HCl Injection, USP, and conversely, some vials labeled to contain 1% Lidocaine HCl Injection, USP may actually contain 0.5% Bupivacaine Hydrochloride Injection, USP. This mix-up poses a risk of patients receiving an incorrect local anesthetic drug or concentration.
The affected vials were distributed nationwide in the USA, Puerto Rico, and Guam. Healthcare providers and patients who have received vials from lot EG6023 should verify the actual contents match the vial label and consult with their healthcare provider regarding any doses already administered. Pfizer distributed the product with NDC 0409-1162-19 (individual vials) and NDC 0409-1162-02 (25 vials per tray).
The recalled product
- Product
- BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
- Brand
- BUPIVACAINE HYDROCHLORIDE
- Manufacturer
- PFIZER, INC
- Affected units
- 163,957
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 (2)
- Lot EG6023
- Exp. 07/01/2022
Distribution
Part of a larger recall action
This product is one of 2 recalled by PFIZER, 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 2 products in this recall →Related recalls
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