Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for injection, Rx Only, Isomeric Pharmacy Solution, 2401 Foothill Dr., Salt Lake City, UT 84109
Reported: August 10, 2016 Initiated: August 1, 2016 #D-1454-2016
Product Description
Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for injection, Rx Only, Isomeric Pharmacy Solution, 2401 Foothill Dr., Salt Lake City, UT 84109
Reason for Recall
Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate 7 mg/mL INJ SUSP because of the potential of drug clumps in the vial of the sterile drug product and larger particle sizes.
Details
- Recalling Firm
- Isomeric Pharmacy Solution, LLC
- Units Affected
- 2,331 vials
- Distribution
- Nationwide and Puerto Rico
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for injection, Rx Only, Isomeric Pharmacy Solution, 2401 Foothill Dr., Salt Lake City, UT 84109. Recalled by Isomeric Pharmacy Solution, LLC. Units affected: 2,331 vials.
Why was this product recalled? ▼
Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate 7 mg/mL INJ SUSP because of the potential of drug clumps in the vial of the sterile drug product and larger particle sizes.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 10, 2016. Severity: Moderate. Recall number: D-1454-2016.
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