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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80118

23 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 17, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Guardian Pharmacy Services

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

Complete imported group

Every recalled product in this event

23 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 23

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

D-1051-2018
Recall number
D-1051-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
20 25-ml CADD

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 58440:42 Use By: 05/23/2018; 58624:42 Use By: 06/11/2018; 58962:42 Use By: 07/11/2018

Distribution pattern

Texas

drug · product 2 of 23

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

D-1052-2018
Recall number
D-1052-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
4900 100-ml vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 58495:42 Use By: 05/22/2018; 58703/58733 Use By: 06/10/2018; 58852:42 Use By: 06/22/2018; 59006:42 Use By: 07/10/2018;

Distribution pattern

Texas

drug · product 3 of 23

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

D-1053-2018
Recall number
D-1053-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
5000 500-ml bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 58555:42, 58567:42, 58563:42, 58547:42, 58565:42, Use By: 05/25/2018

Distribution pattern

Texas

drug · product 4 of 23

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

D-1054-2018
Recall number
D-1054-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
2600 100 ml bags/vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: a) 58572:42 Use By: 05/29/2018 b) 58768:42 Use By: 06/20/2018;

Distribution pattern

Texas

drug · product 5 of 23

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

D-1055-2018
Recall number
D-1055-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
1 1-ml syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 58897:42 Use By: 07/04/2018

Distribution pattern

Texas

drug · product 6 of 23

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

D-1056-2018
Recall number
D-1056-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
2400 100-ml vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 58436:42 Use By: 05/22/2018; 58653:42 Use By: 06/12/2018; 58773:42, 58766:42, Use By: 06/21/2018; 58766:42 Use By: 06/20/2018;

Distribution pattern

Texas

drug · product 7 of 23

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

D-1057-2018
Recall number
D-1057-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
100 2-ml syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 58811:93 Use By: 06/18/2018

Distribution pattern

Texas

drug · product 8 of 23

Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

D-1058-2018
Recall number
D-1058-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
2 1-ml vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 58895:42 Use By: 06/27/2018

Distribution pattern

Texas

drug · product 9 of 23

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

D-1059-2018
Recall number
D-1059-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
442 1-ml syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 58895:42 Use By: 06/27/2018; 58856:42 Use By: 06/21/2018;

Distribution pattern

Texas

drug · product 10 of 23

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

D-1060-2018
Recall number
D-1060-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
1000 100-ml vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 58212:42 Use By: 06/01/2018

Distribution pattern

Texas

drug · product 11 of 23

Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

D-1061-2018
Recall number
D-1061-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
60 5-ml vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 58611:42 Use By: 06/07/2018; 59099:42 Use By: 07/24/2018; 58786:42 Use By: 06/24/2018

Distribution pattern

Texas

drug · product 12 of 23

Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

D-1062-2018
Recall number
D-1062-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
95 1-ml syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 59185:42 Use By: 07/30/2018; 58471:42 Use By: 05/27/2018; 58745:42 Use By: 06/10/2018;

Distribution pattern

Texas

drug · product 13 of 23

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

D-1063-2018
Recall number
D-1063-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
300 2-ml syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 58854:42 Use By: 06/28/2018;

Distribution pattern

Texas

drug · product 14 of 23

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

D-1064-2018
Recall number
D-1064-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
20 400-ml ON-Q Pump

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 59088:42 Use By: 05/24/2018; 59159:42 Use By: 05/30/2018

Distribution pattern

Texas

drug · product 15 of 23

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

D-1065-2018
Recall number
D-1065-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
25 550-ml ON-Q Pump

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 59086:42 Use By: 05/24/2018; 59163:42 Use By: 05/30/2018

Distribution pattern

Texas

drug · product 16 of 23

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

D-1066-2018
Recall number
D-1066-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
3 750-ml ON-Q Pump

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 59103:42 Use By: 05/25/2018

Distribution pattern

Texas

drug · product 17 of 23

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

D-1067-2018
Recall number
D-1067-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
60 20-ml syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 58758; 58760; 58756, 59095:42, 59093:42; 59091:42

Distribution pattern

Texas

drug · product 18 of 23

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

D-1068-2018
Recall number
D-1068-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
100 50-ml vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 58653:42 Use By: 06/12/2018; 58773/58766 Use By: 06/21/2018; 58766:42 Use By: 06/20/2018;

Distribution pattern

Texas

drug · product 19 of 23

Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

D-1069-2018
Recall number
D-1069-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
250 10-ml syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 58641:42 Use By: 06/04/2018; 58775:42 Use By: 06/16/2018; 59077:42 Use By: 07/17/2018

Distribution pattern

Texas

drug · product 20 of 23

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

D-1070-2018
Recall number
D-1070-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
100 50-ml vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 59097:42 Use By: 07/23/2018

Distribution pattern

Texas

drug · product 21 of 23

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

D-1071-2018
Recall number
D-1071-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
2000 100-ml vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 58409:42, Use By: 05/21/2018; 58899:42, Use By: 07/04/2018; 59215:42 Use By: 08/01/2018

Distribution pattern

Texas

drug · product 22 of 23

MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

D-1072-2018
Recall number
D-1072-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
250 50-ml vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 58618:42 UB, Use By: 06/10/2018

Distribution pattern

Texas

drug · product 23 of 23

Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

D-1073-2018
Recall number
D-1073-2018
Initiated
May 17, 2018
Classification
Class II
Status
Terminated
Quantity
40 10-ml vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 58913:42 Use By: 06/05/2018

Distribution pattern

Texas