CLASS II Drug recall · Reported 25 Jun 2014 · FDA Enforcement Report
Cyanocobalamin For Intramuscular OR Subcutaneous Use Only recalled
John W Hollis is recalling Cyanocobalamin For Intramuscular OR Subcutaneous Use Only, Each mL contains, distributed nationwide in the US. The recall was initiated on 12 May 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-1390-2014
- FDA event ID
- 68557
- Recalling firm
- John W Hollis, Nashville, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 May 2014
- FDA classified
- 18 Jun 2014
- Reported
- 25 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 12 May 2014 | Recall initiated by company | |
| 18 Jun 2014 | Classified by FDA | +37 days |
| 25 Jun 2014 | 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: Lack of sterility assurance in compounded aseptically filled injectable products.
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 FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Each mL contains: Cyanocobalamin 1000 mcg, , Also Contains: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Which lots are affected?
Lot # 940, Best used by 08/01/14; Lot # 1090, Best used by 08/29/14; Lot # 1533, Best used by 05/24/14; Lot # 1838, Best used by 07/15/14; Lot# 2755, Best used by 10/06/14
Where was it sold?
Nationwide
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
18 other products · FDA event 68557This product is part of a recall event; the main page for the event is Polidocanol 1% Solution for Injection recalled by John W Hollis.
More recalls from John W Hollis
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | MIC PLUS B12, Adenosine, L-Carnitine, Contains recalled by John W Hollis | John W Hollis | Sterility | Nationwide |
| Drug | CLASS II | Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) and b) recalled | John W Hollis | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate for Injection recalled by John W Hollis | John W Hollis | Sterility | Nationwide |
| Drug | CLASS II | Methylcobalamin For Intramuscular OR Subcutaneous Use Only recalled | John W Hollis | Sterility | Nationwide |
| Drug | CLASS II | B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate recalled | John W Hollis | Sterility | Nationwide |