CLASS II Drug recall · Reported 3 May 2017 · FDA Enforcement Report
Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol recalled
Isomeric Pharmacy Solution is recalling Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, distributed nationwide in the US. The recall was initiated on 6 Apr 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0685-2017
- FDA event ID
- 76951
- Recalling firm
- Isomeric Pharmacy Solution, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Apr 2017
- FDA classified
- 26 Apr 2017
- Reported
- 3 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Apr 2017 | Recall initiated by company | |
| 26 Apr 2017 | Classified by FDA | +20 days |
| 3 May 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Which lots are affected?
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.
Where was it sold?
Nationwide in the USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 76951| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Triamcinolone Diacetate 40 mg/mL Multi-Dose Vial For Injection recalled | Isomeric Pharmacy Solution | Sterility | Nationwide | |
| CLASS II | Testosterone Cypionate 200 mg/mL recalled by Isomeric Pharmacy Solution | Isomeric Pharmacy Solution | Sterility | Nationwide | |
| CLASS II | Triamcinolone Acetonide 40 mg/mL recalled by Isomeric Pharmacy Solution | Isomeric Pharmacy Solution | Sterility | Nationwide | |
| CLASS II | Methylprednisolone Acetate 40 mg/mL recalled | Isomeric Pharmacy Solution | Sterility | Nationwide | |
| CLASS II | Phenylephrine 2.5%, Tropicamide 1% Multi-Dose Ophthalmic recalled | Isomeric Pharmacy Solution | Sterility | Nationwide | |
| CLASS II | Methylprednisolone Acetate 80 mg/mL recalled | Isomeric Pharmacy Solution | Sterility | Nationwide |
More recalls from Isomeric Pharmacy Solution
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylprednisolone Acetate 80 mg/mL recalled | Isomeric Pharmacy Solution | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine 2.5%, Tropicamide 1% Multi-Dose Ophthalmic recalled | Isomeric Pharmacy Solution | Sterility | Nationwide |
| Drug | CLASS II | Methylprednisolone Acetate 40 mg/mL recalled | Isomeric Pharmacy Solution | Sterility | Nationwide |
| Drug | CLASS II | Triamcinolone Acetonide 40 mg/mL recalled by Isomeric Pharmacy Solution | Isomeric Pharmacy Solution | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate 200 mg/mL recalled by Isomeric Pharmacy Solution | Isomeric Pharmacy Solution | Sterility | Nationwide |
Other Cyanocobalamin recalls
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only recalledCyanocobalamin | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Cyanocobalamin injection USP, 10,000 mcg/ (1,000 mcg/mL) recalledCyanocobalamin | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Cyanocobalamin Injection, USP, 1,000mcg/mL Multiple-Dose Vial recalled | Zydus Pharmaceuticals | Particulate Matter | TN |
| Drug | CLASS II | Cyanocobalamin 2 mg/mL, Multi-Dose vial recalled | Olympia Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS III | Cyanocobalamin Injection, USP, 1000 mcg per mL recalled | American Health Packaging | Potency & Assay | AL |