Recall events
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Event 80303
Event summary
Timeline bucket June 14, 2018
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording SCA Pharmaceuticals, LLC
Dossier provenance
Source snapshots represented here
openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
Complete imported group
Every recalled product in this event
12 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 12
Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT
D-0894-2018
Recall number D-0894-2018
Initiated June 14, 2018
Classification Class II
Status Terminated
Quantity 440 syringes
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Code information Lot # 20180323@44, Exp 06/21/2018
Distribution pattern Product was distributed throughout the United States.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[1492]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 12
Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
D-0895-2018
Recall number D-0895-2018
Initiated June 14, 2018
Classification Class II
Status Terminated
Quantity 492 bags
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Code information Lot # 20180328@19, 20180328@31, 20180328@39, 20180328@49, 20180328@53, 20180328@58, 20180323@9, 20180327@33, Exp 6/26/2018
Distribution pattern Product was distributed throughout the United States.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[2229]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 12
Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
D-0896-2018
Recall number D-0896-2018
Initiated June 14, 2018
Classification Class II
Status Terminated
Quantity 179 bags
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Code information Lot # 20180327@27, 20180327@40, 20180328@9, Exp 06/28/2018
Distribution pattern Product was distributed throughout the United States.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[4303]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 12
Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT
D-0897-2018
Recall number D-0897-2018
Initiated June 14, 2018
Classification Class II
Status Terminated
Quantity 2,869 bags
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Code information Lot # 1218001315, 1218001316, 1218001349, 1218001416, 1218001510, 1218001682, 1218001683, 1218001684, 1218001721, 1218001763, 1218001764, Exp 07/26/2018-08/27/2018
Distribution pattern Product was distributed throughout the United States.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[4178]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 12
Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
D-0898-2018
Recall number D-0898-2018
Initiated June 14, 2018
Classification Class II
Status Terminated
Quantity 2,268 bags
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Code information Lot # 1218000928, 1218000944, 1218000945, 1218001075, 1218001076, 1218001188, Exp 06/19/2018-07/03/2018
Distribution pattern Product was distributed throughout the United States.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[2117]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 12
Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
D-0899-2018
Recall number D-0899-2018
Initiated June 14, 2018
Classification Class II
Status Terminated
Quantity 1,882 bags
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Code information Lot # 1218000930, 1218000946, 1218001058, 1218001077, 1218001169, 1218001170, 1218001190, 1218001191, 1218001206, 1218001317, Exp 06/18/2018-07/11/2018
Distribution pattern Product was distributed throughout the United States.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[4180]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 12
Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
D-0900-2018
Recall number D-0900-2018
Initiated June 14, 2018
Classification Class II
Status Terminated
Quantity 1,397 bags
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Code information Lot # 1218000677, 1218000947, 1218000982, 1218001018, 1218001029, 1218001059, 1218001060, 1218001078, 1218001079, 1218001171, 1218001172, 1218001192, 1218001193, 1218001207, 1218001209, 1218001210, Exp 06/19/2018-07/03/2018
Distribution pattern Product was distributed throughout the United States.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[2226]
FDA event record
· Exact recall-number query on openFDA
drug · product 8 of 12
Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
D-0901-2018
Recall number D-0901-2018
Initiated June 14, 2018
Classification Class II
Status Terminated
Quantity 451 bags
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Code information Lot # 20180323@24, Exp 06/21/2018
Distribution pattern Product was distributed throughout the United States.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[1759]
FDA event record
· Exact recall-number query on openFDA
drug · product 9 of 12
Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
D-0902-2018
Recall number D-0902-2018
Initiated June 14, 2018
Classification Class II
Status Terminated
Quantity 451 bags
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Code information Lot # 20180323@24
Distribution pattern Product was distributed throughout the United States.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[2617]
FDA event record
· Exact recall-number query on openFDA
drug · product 10 of 12
Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
D-0903-2018
Recall number D-0903-2018
Initiated June 14, 2018
Classification Class II
Status Terminated
Quantity 400 bags
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Code information Lot # 20180323@29, Exp 06/21/2018
Distribution pattern Product was distributed throughout the United States.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[4177]
FDA event record
· Exact recall-number query on openFDA
drug · product 11 of 12
Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
D-0904-2018
Recall number D-0904-2018
Initiated June 14, 2018
Classification Class II
Status Terminated
Quantity Unavailable
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Code information Lot # 20180329@2, Exp 06/27/2018
Distribution pattern Product was distributed throughout the United States.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[4305]
FDA event record
· Exact recall-number query on openFDA
drug · product 12 of 12
Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
D-0905-2018
Recall number D-0905-2018
Initiated June 14, 2018
Classification Class II
Status Terminated
Quantity 196 bags
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Code information Lot # 20180328@25, Exp 06/26/2018
Distribution pattern Product was distributed throughout the United States.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[1486]
FDA event record
· Exact recall-number query on openFDA
