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
Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Lot numbers, UPCs & expiration codes
Lot #: a) 06042015@15, Exp 06/18/15; 06052015@3, Exp 06/19/15; b) 06082015@21, Exp 06/22/15
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-1387-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 15, 2015
- FDA report date
- Sep 2, 2015
- Quantity
- 3 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Liberty Drug & Surgical
Original FDA data
Every field from FDA enforcement report D-1387-2015, 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 #: a) 06042015@15, Exp 06/18/15; 06052015@3, Exp 06/19/15; b) 06082015@21, Exp 06/22/15
- Postal code
- 07928-2405
- Report date
- Sep 2, 2015
- Product type
- Drugs
- Recall number
- D-1387-2015
- Classification
- Class II
- Recalling firm
- Liberty Drug & Surgical
- Product quantity
- 3 bottles
- 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
- Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15 mL bottle, 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