CLASS II Drug recall · Reported 4 Nov 2015 · FDA Enforcement Report
Methylcobalamin 1000MCG/ML vial recalled by Chen Shwezin
Chen Shwezin is recalling Methylcobalamin 1000MCG/ML vial, distributed in California. The recall was initiated on 6 Oct 2015 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-0157-2016
- FDA event ID
- 72402
- Recalling firm
- Chen Shwezin, Westlake Village, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Oct 2015
- FDA classified
- 28 Oct 2015
- Reported
- 4 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Oct 2015 | Recall initiated by company | |
| 28 Oct 2015 | Classified by FDA | +22 days |
| 4 Nov 2015 | 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: all sterile compounded products within expiry
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
METHYLCOBALAMIN 1000MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258
Where it was distributed
CA
Questions about this recall
Is Methylcobalamin 1000MCG/ML vial recalled?
Yes. Chen Shwezin recalled Methylcobalamin 1000MCG/ML vial on 6 Oct 2015. The recall is Class II and its status is Terminated. Recall number D-0157-2016.
Why was it recalled?
Lack of Assurance of Sterility: all sterile compounded products within expiry
Which lots are affected?
Lot#: 09102015@6, Exp 3/8/16
Where was it sold?
CA
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 21 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 Chen Shwezin
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tri-mix 10MCG+0.5MG+15MG/ML vial recalled by Chen Shwezin | Chen Shwezin | Sterility | CA |
| Drug | CLASS II | Prostaglandin Pge-1 40MCG/ML vial recalled by Chen Shwezin | Chen Shwezin | Sterility | CA |
| Drug | CLASS II | Caffeine + Sodium Benzoate 500MG/ML vial recalled by Chen Shwezin | Chen Shwezin | Sterility | CA |
| Drug | CLASS II | Tri-mix 20MCG+0.5MG+15MG/ML vial recalled by Chen Shwezin | Chen Shwezin | Sterility | CA |