Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported January 13, 2021
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
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Sca Pharmaceuticals recalled Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485… - a moderate-severity action.
Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485… was recalled by Sca Pharmaceuticals in January 13, 2021. Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit. Check the official notice for the remedy. Verify recall #D-0211-2021 with the FDA Drug before acting.
The recall
Sca Pharmaceuticals issued this moderate-severity FDA Drug recall-Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit.
- Moderate
- severity level
- Class II
- classification
- January 13, 2021
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0211-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0211-2021) was formally reported on January 13, 2021, with the manufacturer initiating the action on December 17, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Sca Pharmaceuticals is listed as the recalling firm, operating out of Windsor, CT. Federal records list the affected scope as 13,096 syringes.
The documented reason for this recall is: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Distribution data in the federal record shows the product reached: Product was distributed to hospitals nationwide.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
13,096 syringes
Related Recalls
6
0 from same agency
Product description
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
Reason for recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0211-2021 |
| Date reported | January 13, 2021 |
| Date initiated | December 17, 2020 |
| Recalling firm | Sca Pharmaceuticals |
| Firm location | Windsor, CT |
| Affected scope | 13,096 syringes |
| Distribution | Product was distributed to hospitals nationwide. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0211-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sca Pharmaceuticals. Units affected: 13,096 syringes.
Why was this product recalled? ▼
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 13, 2021. Severity: Moderate. Recall number: D-0211-2021.
Where was the recalled product distributed? ▼
Distribution: Product was distributed to hospitals nationwide..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0211-2021) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported January 13, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.