Exact FDA event identifier

Event 76951

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

Event summary

Timeline bucket: April 06, 2017
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Isomeric Pharmacy Solution, 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

7 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 7

Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1010, barcode 3 70285 10101 4.

D-0681-2017

Recall number: D-0681-2017
Initiated: April 06, 2017
Classification: Class II
Status: Terminated
Recalling firm: Isomeric Pharmacy Solution, LLC
Quantity: 4,001 vials

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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #s: 09007, Exp 04/04/17; 09016, Exp 04/16/17; 09020, Exp 04/18/17; 09025, Exp 04/23/17; 10026, 10030, Exp 05/28/17; 11007, Exp 05/30/17; 11008, Exp 05/31/17; 11020, Exp 06/07/17; 11028, Exp 06/12/17; 11043, Exp 06/26/17.

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 2 of 7

Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1011, barcode 3 70285 10111 3.

D-0682-2017

Recall number: D-0682-2017
Initiated: April 06, 2017
Classification: Class II
Status: Terminated
Recalling firm: Isomeric Pharmacy Solution, LLC
Quantity: 2,352 vials

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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #s: 09022, Exp 04/22/17; 10001, Exp 05/02/17; 11001, Exp 05/31/17; 11010, Exp 06/03/17; 11037, Exp 06/19/17; 11041, Exp 06/25/17.

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 3 of 7

Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1020, barcode 3 70285 10201 1.

D-0683-2017

Recall number: D-0683-2017
Initiated: April 06, 2017
Classification: Class II
Status: Terminated
Recalling firm: Isomeric Pharmacy Solution, LLC
Quantity: 2,335 vials

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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #s: 09032, Exp 04/06/17; 10017, Exp 04/19/17; 10022, Exp 04/26/17; 10031, Exp 05/04/17; 11021, Exp 05/17/17; 12007, Exp 06/16/17.

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 4 of 7

Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0.

D-0684-2017

Recall number: D-0684-2017
Initiated: April 06, 2017
Classification: Class II
Status: Terminated
Recalling firm: Isomeric Pharmacy Solution, LLC
Quantity: 1,951 vials

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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #s: 10013, Exp 05/10/17; 10020, Exp 05/20/17; 10029, Exp 05/27/17; 11002, Exp 05/30/17; 11013, Exp 06/04/17.

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 5 of 7

Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9.

D-0685-2017

Recall number: D-0685-2017
Initiated: April 06, 2017
Classification: Class II
Status: Terminated
Recalling firm: Isomeric Pharmacy Solution, LLC
Quantity: 851 vials

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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #s: 09003, Exp 04/17/17; 11003, Exp 06/21/17; 11035, Exp 07/03/17; 11039, Exp 07/05/17; 12002, Exp 07/23/17; 12012, Exp 07/30/17.

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 6 of 7

Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1200, barcode 3 70285 12003 9.

D-0686-2017

Recall number: D-0686-2017
Initiated: April 06, 2017
Classification: Class II
Status: Terminated
Recalling firm: Isomeric Pharmacy Solution, LLC
Quantity: 2,156 vials

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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #s: 09018, Exp 04/17/17; 09023, Exp 04/22/17; 09024, Exp 04/23/17; 09027, Exp 04/25/17; 09031, Exp 04/30/17; 10005, Exp 05/06/17; 10010, Exp 05/09/17; 11022, Exp 06/10/17; 11038, Exp 06/18/17; 11044, Exp 07/04/17; 12003, Exp 07/08/17; 12010, Exp 07/12/17; 12021, Exp 07/30/17.

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 7 of 7

Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1300, barcode 3 70285 13001 4.

D-0687-2017

Recall number: D-0687-2017
Initiated: April 06, 2017
Classification: Class II
Status: Terminated
Recalling firm: Isomeric Pharmacy Solution, LLC
Quantity: 5,165 bottles

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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot Numbers: 10003, Exp 04/05/17; 10018, Exp 04/17/17; 10023, Exp 04/23/17; 10025, Exp 04/24/17; 10027, Exp 04/29/17; 11011, 11012, Exp 05/07/17; 11024, 11026, Exp 05/14/17; 11029, Exp 05/16/17; 11030, Exp 05/17/17; 11032, Exp 05/21/17; 11045, Exp 06/04/17; 12008, Exp 06/13/17; 12014, 12015, Exp 06/20/17; 12022, 12024, Exp 06/28/17; 13001, 13002, Exp 07/03/17; 13011, 13012, Exp 07/09/17.

Distribution pattern

Nationwide in the USA and Puerto Rico