Class II · Moderate risk
Betamethasone Dipropionate Ointment USP
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What 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
Drug: Betamethasone
- Recalling firm
- Isomeric Pharmacy Solution, LLC
- Origin
- UT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1454-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Betamethasone recalls
See all
Class II · Moderate risk
Celestone Soluspan
cGMP deviations: Temperature abuse
Class II · Moderate risk
Betamethasone Dipropionate Cream USP
cGMP deviations: Temperature abuse
Class II · Moderate risk
Betamethasone Dipropionate Lotion USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class III · Low risk
Clotrimazole and Betamethasone Dipropionate Cream USP
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Other recalls by Isomeric Pharmacy Solution, LLC
All 2016 recalls
Class II · Moderate risk
Phenylephrine 2.5%
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Testosterone Cypionate 200 mg/mL
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Triamcinolone Diacetate 40 mg/mL
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
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