Why it was recalled
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Product description
Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Lot numbers, UPCs & expiration codes
Lot #: 05152015@2, Exp 06/29/15
Where it was sold
Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY
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-1380-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 15, 2015
- FDA report date
- Sep 2, 2015
- Quantity
- 6 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Liberty Drug & Surgical
Original FDA data
Every field from FDA enforcement report D-1380-2015, exactly as published.
Show all FDA fields
- City
- Chatham
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 71591
- Address
- 195 Main St
- Code information
- Lot #: 05152015@2, Exp 06/29/15
- Postal code
- 07928-2405
- Report date
- Sep 2, 2015
- Product type
- Drugs
- Recall number
- D-1380-2015
- Classification
- Class II
- Recalling firm
- Liberty Drug & Surgical
- Product quantity
- 6 syringes
- Termination date
- Apr 23, 2018
- Reason for recall
- Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
- Distribution pattern
- Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY
- Recall initiation date
- Jun 15, 2015
- Initial firm notification
- Telephone
- Center classification date
- Aug 27, 2015