Manufacturer

SCA Pharmaceuticals, LLC.

57 recalls in our database name SCA Pharmaceuticals, LLC. as the manufacturing or recalling firm.

What the numbers show

Total: 57
Critical: 0
Severe: 19
Most recent: 2024-04-03

Of the 57 recalls from SCA Pharmaceuticals, LLC. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 19 (33%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 57

HighFDA (Drugs)·D-0394-2024·2024-04-03
Diltiazem HCl Injection Lacks Sterility Assurance; SCA Pharmaceuticals Recalls
SCA Pharmaceuticals is recalling Diltiazem HCl 125 mg Injectable (381 bags) due to lack of sterility assurance. Patients and healthcare providers should not use affected units from lot #1223049625.
Product
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0399-2024·2024-04-03
FDA Recalls Fentanyl and Bupivacaine Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling 324 syringes of fentanyl/bupivacaine epidural injection nationwide due to lack of sterility assurance. Patients should contact their healthcare provider if affected.
Product
fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-0231-22, Bar Code 70004023122
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0400-2024·2024-04-03
Fentanyl and Bupivacaine Epidural Injection Recalled for Sterility Assurance Issue
SCA Pharmaceuticals recalls 412 cassettes of fentanyl-bupivacaine epidural injection (lots 1223049261 and 1223049724) due to lack of assurance of sterility.
Product
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0289-64, Bar Code 70004028964
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0419-2024·2024-04-03
Pharmaceutical Injection Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals is recalling PHENYLephrine HCl 40 mg injection nationwide due to lack of sterility assurance. Patients should contact their healthcare provider and not use this product.
Product
PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0420-2024·2024-04-03
PHENYLephrine HCl Injectable Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals is recalling PHENYLephrine HCl 800 mcg/10 mL injections due to lack of assurance of sterility. The recall affects 3,671 syringes distributed nationwide.
Product
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code 700040081612.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0407-2024·2024-04-03
Hydromorphone Injection Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals recalls 1,023 syringes of Hydromorphone Injection nationwide due to lack of sterility assurance. No illnesses have been reported.
Product
HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0424-2024·2024-04-03
Succinylcholine Chloride Injection Recalled for Sterility Assurance Failure
SCA Pharmaceuticals is recalling 5,079 syringes of Succinylcholine Chloride Injection nationwide due to lack of sterility assurance. Affected lots are #1223049085 and #1223049364.
Product
SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-09, Bar Code 70004090809
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0620-2020·2019-12-18
SCA Pharmaceuticals Recalls Lidocaine Syringes Due to Foreign Material
SCA Pharmaceuticals is recalling Lidocaine HCl 2% syringes because foreign material was found inside the vials.
Product
Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1843-2019·2019-08-28
SCA Pharmaceuticals Recalls Ketamine Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling 922 syringes of Ketamine 50 mg/5 mL injection due to a lack of assurance of sterility. The product was distributed nationwide.
Product
Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0897-2018·2018-07-11
SCA Pharmaceuticals Recalls Diltiazem HCL Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling specific lots of Diltiazem HCL sterile admixtures due to a potential for leakage that compromises sterility.
Product
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
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0902-2018·2018-07-11
SCA Pharmaceuticals Recalls Phenylephrine Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling 451 bags of Phenylephrine HCL due to potential leakage that compromises sterility.
Product
Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0894-2018·2018-07-11
SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling specific lots of Morphine Sulfate 1 mg/mL syringes due to a potential for leakage that compromises sterility.
Product
Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0898-2018·2018-07-11
SCA Pharmaceuticals Recalls Norepinephrine Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate bags due to a potential for leakage that compromises sterility.
Product
Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0905-2018·2018-07-11
SCA Pharmaceuticals Recalls Phenylephrine Bags Due to Leakage Risk
SCA Pharmaceuticals is voluntarily recalling 196 bags of Phenylephrine HCL 80mg in 0.9% Sodium Chloride due to a potential for leakage that compromises sterility.
Product
Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0895-2018·2018-07-11
SCA Pharmaceuticals Recalls Fentanyl Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling 492 bags of Fentanyl admixture due to a potential for leakage that compromises sterility.
Product
Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0903-2018·2018-07-11
SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling 400 bags of Phenylephrine HCL 20 mg in 0.9% Sodium Chloride due to a potential for leakage that compromises sterility.
Product
Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0901-2018·2018-07-11
SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Leakage Risk
SCA Pharmaceuticals is voluntarily recalling 451 bags of Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL due to a potential for leakage that compromises sterility.
Product
Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0899-2018·2018-07-11
SCA Pharmaceuticals Recalls Norepinephrine Bitartrate Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate 8 mg bags due to a potential for leakage that compromises sterility.
Product
Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0904-2018·2018-07-11
SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Leakage Risk
SCA Pharmaceuticals is voluntarily recalling specific lots of Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL bags due to a potential for leakage that compromises sterility.
Product
Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0900-2018·2018-07-11
SCA Pharmaceuticals Recalls Norepinephrine Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate bags due to a potential for leakage that compromises sterility.
Product
Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0896-2018·2018-07-11
SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Bags Due to Leakage Risk
SCA Pharmaceuticals is voluntarily recalling specific lots of sterile fentanyl and bupivacaine admixture bags due to a potential for leakage that compromises sterility.
Product
Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-0603-2018·2018-03-14
SCA Pharmaceuticals Recalls Labetalol HCl Injection Due to Labeling Errors
SCA Pharmaceuticals is recalling 480 syringes of labetalol HCl injection because some labels display incorrect compounding and use-by dates.
Product
labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028
Category
Drug
Distribution
3 states
SevereFDA (Drugs)·D-0065-2018·2017-11-08
SCA Pharmaceuticals Recalls Oxytocin Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling 450 bags of oxyTOCIN 30 units in Lactated Ringers due to a lack of assurance of sterility.
Product
oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0068-2018·2017-11-08
SCA Pharmaceuticals Recalls Rocuronium Bromide Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 487 syringes of Rocuronium Bromide 10 mg/mL due to a lack of assurance of sterility. The product was distributed nationwide.
Product
ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-850-09
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0067-2018·2017-11-08
SCA Pharmaceuticals Recalls Calcium Gluconate Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling 76 bags of Calcium Gluconate 2 g in 0.9% Sodium Chloride due to a lack of assurance of sterility.
Product
Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0510-30
Category
Drug
Distribution
Distributed nationwide