Recalls / Class I
Class ID-1248-2019
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
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
- Brand name
- Marbeta L Kit
- Generic name
- Betamethasone Sodium Phosphate, Betamethasone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Isopropyl Alcohol
- Route
- Epidural, Infiltration, Intra-articular, Intralesional, Intramuscular, Topical
- NDC
- 76420-782
- Affected lot / code info
- Lot #: CLC180117, Exp. June 2021
Why it was recalled
Presence of Particulate Matter: One vial was found to contain a hair.
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Asclemed USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 88600 vials
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2019-03-28
- FDA classified
- 2019-04-25
- Posted by FDA
- 2019-04-17
- Terminated
- 2024-04-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1248-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.