Food, drugs, devices › SCA Pharmaceuticals, LLC.
Drug recall: labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 -
SCA Pharmaceuticals, LLC. (Windsor, CT) initiated this drug recall on 22 Feb 2018; FDA lists 1 product record under event 79265, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 29% of the 367 drug enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 26 Feb 2019. Initiation: voluntary: firm initiated. SCA Pharmaceuticals, LLC. has 6 enforcement events on this register, with a median of 10 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
SCA Pharmaceuticals, LLC., Windsor, CT.
Reason for recall
"Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018"
Distribution
"GA, NE & PA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0603-2018 | 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 | 480 syringes | Class III | Terminated | 14 Mar 2018 |
Context
Other enforcement events for SCA Pharmaceuticals, LLC.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 9 Nov 2023 | Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceutical | Drug | Class II | 32 |
| 26 Nov 2019 | Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09 | Drug | Class II | 1 |
| 16 Aug 2019 | 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 | Drug | Class II | 1 |
| 14 Jun 2018 | Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT | Drug | Class II | 12 |
| 19 Oct 2017 | SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA P | Drug | Class II | 10 |
All 6 events for SCA Pharmaceuticals, LLC.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "GA, NE & PA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 26 Feb 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.