Recalls / Class I
Class ID-0218-2017
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
- Brand name
- Bupivacaine Hydrochloride
- Generic name
- Bupivacaine Hydrochloride
- Active ingredient
- Bupivacaine Hydrochloride
- Route
- Epidural, Infiltration, Intracaudal, Perineural
- NDCs
- 0409-1159, 0409-1160, 0409-1162, 0409-1163, 0409-1165, 0409-9043, 0409-9046, 0409-9045, 0409-9042
- FDA application
- ANDA070583
- Affected lot / code info
- Lot # 59064DK, Exp. 11/17
Why it was recalled
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Recalling firm
- Firm
- Hospira Inc., A Pfizer Company
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 143,250 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-08-04
- FDA classified
- 2016-12-22
- Posted by FDA
- 2016-12-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0218-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.