Why it was recalled
Non-Sterility: The firm's contract testing laboratory found sterility failures.
Product description
Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231.
Lot numbers, UPCs & expiration codes
Lot #: 05152013@4 (also written as 051513-4), Exp 11/11/13
Where it was sold
Two hospitals in Dallas, TX
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-0250-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 31, 2013
- FDA report date
- Nov 26, 2014
- Quantity
- 1,100 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Abrams Royal Pharmacy
Original FDA data
Every field from FDA enforcement report D-0250-2015, exactly as published.
Show all FDA fields
- City
- Dallas
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 68283
- Address
- 8220 Abrams Rd
- Code information
- Lot #: 05152013@4 (also written as 051513-4), Exp 11/11/13
- Postal code
- 75231-1402
- Report date
- Nov 26, 2014
- Product type
- Drugs
- Recall number
- D-0250-2015
- Classification
- Class I
- Recalling firm
- Abrams Royal Pharmacy
- Product quantity
- 1,100 vials
- Termination date
- Aug 3, 2016
- Reason for recall
- Non-Sterility: The firm's contract testing laboratory found sterility failures.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231.
- Distribution pattern
- Two hospitals in Dallas, TX
- Recall initiation date
- May 31, 2013
- Initial firm notification
- Telephone
- Center classification date
- Nov 17, 2014