Why it was 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.
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
Lot numbers, UPCs & expiration codes
Lot# 03037, Exp 8/17/16; 03042, 03043, Exp 8/31/16; 04043, Exp 9/29/16; 04047, 04048, Exp 10/1/16; 04052, 04053, Exp10/2/16; 05042, Exp 10/29/16; 05046, Exp 11/2/16; 05048, 05049, Exp 11/3/16; 05050 Exp 11/4/16
Where it was sold
Nationwide and Puerto Rico
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-1454-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 1, 2016
- FDA report date
- Aug 10, 2016
- Quantity
- 2,331 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Isomeric Pharmacy Solution, LLC
Original FDA data
Every field from FDA enforcement report D-1454-2016, exactly as published.
Show all FDA fields
- City
- Salt Lake City
- State
- UT
- Status
- Terminated
- Country
- United States
- Event ID
- 74832
- Address
- 2401 S Foothill Dr
- Code information
- Lot# 03037, Exp 8/17/16; 03042, 03043, Exp 8/31/16; 04043, Exp 9/29/16; 04047, 04048, Exp 10/1/16; 04052, 04053, Exp10/2/16; 05042, Exp 10/29/16; 05046, Exp 11/2/16; 05048, 05049, Exp 11/3/16; 05050 Exp 11/4/16
- Postal code
- 84109-1479
- Report date
- Aug 10, 2016
- Product type
- Drugs
- Recall number
- D-1454-2016
- Classification
- Class II
- Recalling firm
- Isomeric Pharmacy Solution, LLC
- Product quantity
- 2,331 vials
- Termination date
- Aug 1, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Aug 1, 2016
- Initial firm notification
- Letter
- Center classification date
- Aug 4, 2016