FDA Recall D-1248-2019
Aurobindo Pharma USA Inc. · East Windsor, NJ
Class I — life-threatening Terminated 1841 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520 NDC 55150-162-05
Reason for recall
Presence of Particulate Matter: One vial was found to contain a hair.
Recall record
- Recall number
D-1248-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product is being held at a distributor site in Mexico, Asheboro, NC, Charlotte, NC and Santa Teresa, NM and not further distributed in the U.S. Market.
- Recall initiated
- 2019-03-28
- Classified by FDA Center
- 2019-04-25
- FDA published
- 2019-04-17
- Terminated
- 2024-04-11
- Recalling firm
- Aurobindo Pharma USA Inc.
- Firm location
- East Windsor, NJ
Drug identification
- Brand name(s)
- MARBETA L KIT
- Generic name(s)
- BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL
- Manufacturer(s)
- Asclemed USA, Inc.
- NDC(s)
76420-782- Route(s)
- EPIDURAL, INFILTRATION, INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, TOPICAL