Recalls / Class II
Class IID-0097-2017
Product
Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.
- Brand name
- Marcaine
- Generic name
- Bupivacaine Hydrochloride
- Active ingredient
- Bupivacaine Hydrochloride
- Route
- Perineural
- NDCs
- 0409-0525, 0409-1559, 0409-1560, 0409-1582, 0409-1587, 0409-1610, 0409-1746, 0409-1749, 0409-1752, 0409-1755 +7 more
- FDA application
- NDA016964
- Affected lot / code info
- Lot #: 59310DD, Exp 1NOV2017
Why it was recalled
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
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
- 4768 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-09-16
- FDA classified
- 2016-10-13
- Posted by FDA
- 2016-10-19
- Terminated
- 2019-07-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0097-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.