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
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
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 (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [2ML] 6MG/ML INJ SUSP, For IM, IA, IT Use, Shake Well. Preservative Free. Discard Unused Portion, 2 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0620-2
Affected NDC
71283-0620-02
Compare with the code on your package — it is the most precise check available.
Drug: Betamethasone
- Recalling firm
- Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- NDC code
- 71283-0620-2
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0942-2020 · 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 Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
All 2020 recalls
Class II · Moderate risk
Zinc Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Cholecalciferol
Lack of Assurance of Sterility
Class II · Moderate risk
Cholecalciferol
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Diacetate Injectable Suspension
Lack of Assurance of Sterility
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