CLASS III Drug recall · Reported 12 Apr 2023 · FDA Enforcement Report
Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL recalled
Accord Healthcare is recalling Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, ML Multiple dose vials, For, distributed nationwide in the US. The recall was initiated on 29 Mar 2023 and the FDA has classified it as Class III.
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-0528-2023
- FDA event ID
- 91977
- Recalling firm
- Accord Healthcare, Durham, NC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 29 Mar 2023
- FDA classified
- 6 Apr 2023
- Reported
- 12 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 29 Mar 2023 | Recall initiated by company | |
| 6 Apr 2023 | Classified by FDA | +8 days |
| 12 Apr 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx Only, Sterile, Manufactured by: Intas Pharmaceuticals Limited Pharmaz Ahnedabad 382 213, INDIA, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-533-08.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Which lots are affected?
Lot #: R2200394 Exp. 03/2024
Where was it sold?
Nationwide in the USA.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Accord Healthcare
All 106| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
Other Dodex Cyanocobalamin recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Dodex Injectable (Cyanocobalamin Injection) recalled | Accord Healthcare | Potency & Assay | Nationwide |