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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

SCA Pharmaceuticals: Injectable Medications Recalled for Potential Lack of Sterility

Agency Publication Date: January 7, 2021
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Summary

SCA Pharmaceuticals is recalling approximately 168,250 units of various injectable medications, including Fentanyl, Morphine, and Ketamine, due to a potential defect in the syringe caps. This defect could compromise the sterile seal of the syringes, potentially leading to contamination. The affected products were distributed to hospitals nationwide between late 2020 and early 2021. Because these are prescription medications used in clinical settings, consumers should check with their healthcare providers to see if they received any of the impacted lots.

Risk

A defective syringe cap can result in a 'non-integral unit,' meaning the medicine is no longer protected by a sterile barrier. This poses a risk of infection or other serious complications if a non-sterile medication is injected into a patient.

What You Should Do

  1. Check any injectable medications provided by your hospital or healthcare facility against the extensive list of affected products, including Rocuronium, Succinylcholine, Ephedrine, Fentanyl, Hydromorphone, Phenylephrine, Ketamine, Atropine, Lidocaine, Esmolol, Glycopyrrolate, Labetalol, Morphine, Neostigmine, and Sodium Citrate.
  2. Identify affected products by checking for specific lot numbers and 'Beyond Use Dates' (BUD) on the syringe label, such as Fentanyl 100 mcg/2mL Lot #1220023109 (BUD 1/25/2021) or Morphine Sulfate 3 mg/3 mL Lot #1220023452 (BUD 2/7/2021).
  3. If you believe you have an affected syringe or have received treatment using one of these medications, contact your healthcare provider or pharmacist immediately for guidance.
  4. Health care facilities should immediately quarantine any remaining stock of the listed lots and contact SCA Pharmaceuticals at 755 Rainbow Rd Ste B, Windsor, CT 06095 to arrange for returns.
  5. Return any unused recalled product to your pharmacy or the place of purchase for a refund and contact SCA Pharmaceuticals for further instructions.
  6. For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare facilities should return unused syringes.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Rocuronium Br 50 mg/5mL (10 mg/mL) Red/White Label
Model:
D-0211-2021
UPC Codes:
7000485009
70004085028
Lot Numbers:
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)
1220023031 (BUD 1/19/2021)
1220023032 (BUD 1/24/2021)
1220023161 (BUD 1/26/2021)
1220023224 (BUD 1/28/2021)
Product: SUCcinylcholine Chloride 100 mg/5mL
Model:
D-0212-2021
UPC Codes:
70004090809
Lot Numbers:
1220023019 (BUD 1/17/2021)
1220023025 (BUD 1/18/2021)
1220023026 (BUD 1/24/2021)
1220023264 (BUD 2/1/2021)
Product: ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection
Model:
D-0213-2021
UPC Codes:
70004060409
Lot Numbers:
1220023022 (BUD 1/17/2021)
1220023023 (BUD 1/17/2021)
1220023029 (BUD 1/19/2021)
1220023030 (BUD 1/20/2021)
1220023117 (BUD 1/25/2021)
1220023145 (BUD 1/26/2021)
1220023166 (BUD 1/27/2021)
Product: fentaNYL 100 mcg/2mL Injection
Model:
D-0214-2021
UPC Codes:
70004020006
Lot Numbers:
1220023109 (BUD 1/25/2021)
1220023255 (BUD 1/26/2021)
1220023256 (BUD 1/26/2021)
1220023257 (BUD 1/28/2021)
1220023334 (BUD 2/2/2021)
1220023518 (BUD 2/8/2021)
Product: HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection
Model:
D-0215-2021
UPC Codes:
70004030022
Lot Numbers:
1220023220 (BUD 1/31/2021)
1220023337 (BUD 2/2/2021)
1220023443 (BUD 2/22/2021)
Product: PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9%
Model:
D-0216-2021
UPC Codes:
70004081022
Lot Numbers:
1220023003 (BUD 12/22/2020)
1220023057 (BUD 12/25/2020)
1220023104 (BUD 12/25/2020)
1220023144 (BUD 12/27/2020)
1220023168 (BUD 12/27/2020)
1220023222 (BUD 12/29/2020)
1220023240 (BUD 12/28/2020)
1220023284 (BUD 1/1/2021)
1220023456 (BUD 1/8/2021)
1220023474 (BUD 1/4/2021)
1220023530 (BUD 1/8/2021)
1220023542 (BUD 1/9/2021)
Product: Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection
Model:
D-0217-2021
UPC Codes:
70004043009
Lot Numbers:
1220023040 (BUD 1/19/2021)
1220023070 (BUD 1/21/2021)
1220023105 (BUD 1/25/2021)
1220023158 (BUD 1/26/2021)
1220023315 (BUD 2/1/2021)
1220023342 (BUD 2/2/2021)
1220023431 (BUD 2/4/2021)
1220023471 (BUD 2/3/2021)
1220023481 (BUD 2/4/2021)
1220023509 (BUD 2/8/2021)
Product: Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL)
Model:
D-0186-2021
UPC Codes:
70004004006
Lot Numbers:
1220023001 (BUD 2/5/2021)
1220023126 (BUD 2/9/2021)
1220023606 (BUD 2/25/2021)
Product: Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL)
Model:
D-0187-2021
UPC Codes:
70004072509
Lot Numbers:
1220023305 (BUD 12/17/2020)
12200223400 (BUD 12/19/2020)
1220023536 (BUD 12/25/2020)
1220023608 (BUD 12/27/2020)
1220023811 (BUD 12/26/2020)
1220023812 (BUD 12/26/2020)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86990
Status: Resolved
Manufacturer: SCA Pharmaceuticals
Sold By: Hospitals nationwide
Manufactured In: United States
Units Affected: 32 products (1,930 syringes; 3,793 syringes; 1,879 syringes; 7,257 syringes; 952 syringes; 1,774 syringes; 996 syringes; 2,834 syringes; 1,614 syringes; 3,092 syringes; 1,056 syringes; 11,075 syringes; 9,057 syringes; 1,880 syringes; 7,275 syringes; 751 syringes; 50 syringes; 390 syringes; 23,029 syringes; 7,890 syringes; 7,940 syringes; 5,990 syringes; 3,239 syringes; 116 syringes; 14,580 syringes; 13,096 syringes; 5067 syringes; 9416 syringes; 6710 syringes; 428 syringes; 3152 syringes; 9942 syringes)
Distributed To: Nationwide

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.