Why it was recalled
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Product description
Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS
Lot numbers, UPCs & expiration codes
Lot#: 389279, Use by 09-09-16
Where it was sold
MS
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1054-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 10, 2015
- FDA report date
- Jul 6, 2016
- Quantity
- 39 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vital Care Compounder
Original FDA data
Every field from FDA enforcement report D-1054-2016, exactly as published.
Show all FDA fields
- City
- Hattiesburg
- State
- MS
- Status
- Terminated
- Country
- United States
- Event ID
- 74539
- Address
- 115 S 40th Ave
- Code information
- Lot#: 389279, Use by 09-09-16
- Postal code
- 39402-6600
- Report date
- Jul 6, 2016
- Product type
- Drugs
- Recall number
- D-1054-2016
- Classification
- Class II
- Recalling firm
- Vital Care Compounder
- Product quantity
- 39 vials
- Termination date
- Nov 17, 2016
- Reason for recall
- Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS
- Distribution pattern
- MS
- Recall initiation date
- Jun 10, 2015
- Initial firm notification
- Telephone
- Center classification date
- Jun 28, 2016