Why it was recalled
Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
Product description
Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY 10605.
Lot numbers, UPCs & expiration codes
Lot #s: 102814, 102914, 103014, 103114, Exp 10/16; 110314, 110414, 110514, 110614, 110714, 111014, Exp 11/16; 121014, 121114, 121214, 121514, Exp 12/16; 011415, 011515, 011615, 012015, 012115, Exp 01/17; 021315, 021715, 021815, 021915, 022015, Exp 02/17; 030415, 030515, 030615, 031015, 031715, Exp 03/17; 042415, 042815, 042915, 043015, Exp 04/17; 050115, 050515, 052815, 052915, Exp 05/17; 060315, 060415, 061615, 061715, Exp 06/17
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-1498-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 10, 2016
- FDA report date
- Sep 14, 2016
- Quantity
- 1,928,075 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Allergy Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1498-2016, exactly as published.
Show all FDA fields
- City
- Oklahoma City
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 74883
- Address
- 1005 SW 2nd St
- Code information
- Lot #s: 102814, 102914, 103014, 103114, Exp 10/16; 110314, 110414, 110514, 110614, 110714, 111014, Exp 11/16; 121014, 121114, 121214, 121514, Exp 12/16; 011415, 011515, 011615, 012015, 012115, Exp 01/17; 021315, 021715, 021815, 021915, 022015, Exp 02/17; 030415, 030515, 030615, 031015, 031715, Exp 03/17; 042415, 042815, 042915, 043015, Exp 04/17; 050115, 050515, 052815, 052915, Exp 05/17; 060315, 060415, 061615, 061715, Exp 06/17
- Postal code
- 73109-1006
- Report date
- Sep 14, 2016
- Product type
- Drugs
- Recall number
- D-1498-2016
- Classification
- Class II
- Recalling firm
- Allergy Laboratories, Inc.
- Product quantity
- 1,928,075 vials
- Termination date
- Mar 13, 2017
- Reason for recall
- Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY 10605.
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 10, 2016
- Initial firm notification
- Telephone
- Center classification date
- Sep 7, 2016