CLASS I Drug recall · Reported 26 Nov 2014 · FDA Enforcement Report
Calcium Chloride Preservative Free Sterile injection, 100 mg/ml vial recalled
Abrams Royal Pharmacy is recalling Calcium Chloride Preservative Free Sterile injection, 100 mg/ml vial, distributed in Texas. The recall was initiated on 31 May 2013 and the FDA has classified it as Class I.
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-0250-2015
- FDA event ID
- 68283
- Recalling firm
- Abrams Royal Pharmacy, Dallas, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 31 May 2013
- FDA classified
- 17 Nov 2014
- Reported
- 26 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 31 May 2013 | Recall initiated by company | |
| 17 Nov 2014 | Classified by FDA | +535 days |
| 26 Nov 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility: The firm's contract testing laboratory found sterility failures.
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
Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231.
Where it was distributed
Two hospitals in Dallas, TX
Questions about this recall
Why was it recalled?
Non-Sterility: The firm's contract testing laboratory found sterility failures.
Which lots are affected?
Lot #: 05152013@4 (also written as 051513-4), Exp 11/11/13
Where was it sold?
Two hospitals in Dallas, TX
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 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 Abrams Royal Pharmacy
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine recalled | Abrams Royal Pharmacy | Sterility | TX |
| Drug | CLASS I | Trace Mineral-5 MDV, supplied in vials, Each ML contains recalled | Abrams Royal Pharmacy | Other Bacterial Contamination | Nationwide |
Other Calcium Chloride Preservative Free recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Calcium Chloride Preservative Free, 100mg/mL, a)-vial recalled | TMC Acquisition | Sterility | Nationwide |