CLASS II Drug recall · Reported 1 Apr 2015 · FDA Enforcement Report
Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx recalled
American Specialty Pharmacy is recalling Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty, distributed in Texas. The recall was initiated on 12 Dec 2014 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-0427-2015
- FDA event ID
- 70013
- Recalling firm
- American Specialty Pharmacy, Plano, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Dec 2014
- FDA classified
- 26 Mar 2015
- Reported
- 1 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Dec 2014 | Recall initiated by company | |
| 26 Mar 2015 | Classified by FDA | +104 days |
| 1 Apr 2015 | 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
Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product
Product as listed by the FDA
Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27
Where it was distributed
TX
Questions about this recall
Why was it recalled?
Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product
Which lots are affected?
Lot# 10082014@10
Where was it sold?
TX
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 Hydroxocobalamin recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydroxocobalamin 25MG/ML vial) Injectable recalled | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Hydroxocobalamin 25mg/mL-vial, Room Temperature recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Hydroxocobalamin Injection, Hydroxocobalamin 5MG/ML recalled | Fusion IV Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Hydroxocobalamin 10 mg/ (0.5 mg/mL) fill in a Vial recalled | KRS Global Biotechnology | Sterility | Nationwide |
| Drug | CLASS II | Hydroxocobalamin 30 mg/ (1 mg/mL) Vial For IM Use recalled | KRS Global Biotechnology | Sterility | Nationwide |