Why it was recalled
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Product description
Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-10
Lot numbers, UPCs & expiration codes
Lot Numbers: 20150104@4 BUD: 9/27/2015; 20150105@1 BUD: 10/27/2015; 20150107@25 BUD: 12/27/2015; 20150306@44 BUD: 11/29/2015; 20150704@49 BUD: 10/3/2015; 20150705@5 BUD: 11/1/2015; 20151106@17 BUD: 12/7/2015; 20151305@5 BUD: 11/8/2015; 20151806@19 BUD: 12/13/2015; 20152005@29 BUD: 11/15/2015; 20152205@7 BUD: 11/16/2015
Where it was sold
Nationwide
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-0238-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 12, 2015
- FDA report date
- Nov 25, 2015
- Quantity
- 19,494 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- US Compounding Inc
Original FDA data
Every field from FDA enforcement report D-0238-2016, exactly as published.
Show all FDA fields
- City
- Conway
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 72179
- Address
- 1270 Don's Lane
- Code information
- Lot Numbers: 20150104@4 BUD: 9/27/2015; 20150105@1 BUD: 10/27/2015; 20150107@25 BUD: 12/27/2015; 20150306@44 BUD: 11/29/2015; 20150704@49 BUD: 10/3/2015; 20150705@5 BUD: 11/1/2015; 20151106@17 BUD: 12/7/2015; 20151305@5 BUD: 11/8/2015; 20151806@19 BUD: 12/13/2015; 20152005@29 BUD: 11/15/2015; 20152205@7 BUD: 11/16/2015
- Postal code
- 72032
- Report date
- Nov 25, 2015
- Product type
- Drugs
- Recall number
- D-0238-2016
- Classification
- Class II
- Recalling firm
- US Compounding Inc
- Product quantity
- 19,494 vials
- Termination date
- Mar 30, 2017
- Reason for recall
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-10
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 12, 2015
- Initial firm notification
- Letter
- Center classification date
- Nov 17, 2015