Drug recall: Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Compounded Guardian Pharmacy Services, 7920…
Class II FDA enforcement event 80118. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of sterility assurance.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Guardian Pharmacy Services started this drug recall on 17 May 2018. The firm address in the FDA record is in Dallas, TX. FDA put the recall in Class II. FDA event 80118 has 23 product records. The first FDA enforcement report date is 15 Aug 2018. The record gives the status Terminated, with the termination date 25 Nov 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Texas
Recalling firm
Guardian Pharmacy Services, Dallas, TX.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
23 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1051-2018 | Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 20 25-ml CADD | Class II | Terminated | 15 Aug 2018 |
| D-1052-2018 | Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 4900 100-ml vials | Class II | Terminated | 15 Aug 2018 |
| D-1053-2018 | Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 5000 500-ml bags | Class II | Terminated | 15 Aug 2018 |
| D-1054-2018 | B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 2600 100 ml bags/vials | Class II | Terminated | 15 Aug 2018 |
| D-1055-2018 | EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 1 1-ml syringe | Class II | Terminated | 15 Aug 2018 |
| D-1056-2018 | Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 2400 100-ml vials | Class II | Terminated | 15 Aug 2018 |
| D-1057-2018 | Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 100 2-ml syringes | Class II | Terminated | 15 Aug 2018 |
| D-1058-2018 | Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 2 1-ml vials | Class II | Terminated | 15 Aug 2018 |
| D-1059-2018 | Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL syringes. Refridgerate. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 442 1-ml syringes | Class II | Terminated | 15 Aug 2018 |
| D-1060-2018 | Magnesium Sulfate 200 mg/mL, 100ml. Rx. Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 1000 100-ml vials | Class II | Terminated | 15 Aug 2018 |
| D-1061-2018 | Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 60 5-ml vials | Class II | Terminated | 15 Aug 2018 |
| D-1062-2018 | Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 95 1-ml syringes | Class II | Terminated | 15 Aug 2018 |
| D-1063-2018 | Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 300 2-ml syringes | Class II | Terminated | 15 Aug 2018 |
| D-1064-2018 | Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 20 400-ml ON-Q Pump | Class II | Terminated | 15 Aug 2018 |
| D-1065-2018 | Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 25 550-ml ON-Q Pump | Class II | Terminated | 15 Aug 2018 |
| D-1066-2018 | Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 3 750-ml ON-Q Pump | Class II | Terminated | 15 Aug 2018 |
| D-1067-2018 | Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 60 20-ml syringes | Class II | Terminated | 15 Aug 2018 |
| D-1068-2018 | Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 100 50-ml vials | Class II | Terminated | 15 Aug 2018 |
| D-1069-2018 | Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 250 10-ml syringes | Class II | Terminated | 15 Aug 2018 |
| D-1070-2018 | Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 100 50-ml vials | Class II | Terminated | 15 Aug 2018 |
| D-1071-2018 | Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 2000 100-ml vials | Class II | Terminated | 15 Aug 2018 |
| D-1072-2018 | MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 250 50-ml vials | Class II | Terminated | 15 Aug 2018 |
| D-1073-2018 | Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | 40 10-ml vials | Class II | Terminated | 15 Aug 2018 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2018
- 367
- Share of these events in Class II
- 60%
- Product records in this event
- 23Median of the firm: 23
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Sep 2016 | Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only Event 75268 | Drug | Class I | 1 |
Official channels
- FDA enforcement report D-1051-2018The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 80118. https://recallregister.com/fda/ii/80118/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Texas
- What quantity of product is in FDA event 80118?
- The event has 23 product records. The first record gives this quantity:
20 25-ml CADD
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2018 have the same class?
- 60% of the 367 drug events that started in 2018 are in Class II.