Recalls / Class II
Class IID-0211-2021
Product
Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 and b) 5 mL Single Dose Syringe White Label (barcode 70004085028), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205
- Affected lot / code info
- a) Lot # 1220023011, BUD 1/12/2021; 1220023027, BUD 1/19/2021; 1220023151, BUD 1/26/2021; 1220023152, BUD 1/26/2021; 1220023194, BUD 1/26/2021; 1220023228, BUD 1/28/2021; 1220023358. BUD 2/3/2021; 1220023396. BUD 2/3/2021; 1220023398, BUD 2/10/2021; 1220023569, BUD 2/9/2021 & 1220023633, BUD 2/11/2021. b)1220023031, BUD 1/19/2021; 1220023032, BUD 1/24/2021; 1220023161, BUD 1/26/2021 & 1220023224, BUD 1/28/2021.
Why it was recalled
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recalling firm
- Firm
- SCA Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 755 Rainbow Rd Ste B, Windsor, Connecticut 06095-1024
Distribution
- Quantity
- 13,096 syringes
- Distribution pattern
- Product was distributed to hospitals nationwide.
Timeline
- Recall initiated
- 2020-12-17
- FDA classified
- 2021-01-07
- Posted by FDA
- 2021-01-13
- Terminated
- 2021-11-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0211-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.