Why it was recalled
Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or expiry date on the outer carton and the potential for illegible/missing lot number and expiry on individual vials.
Product description
etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per carton (NDC 0069-0006-01) and b) 40 mg/20 mL (2 mg/mL) 20 mL Single Dose Vials (NDC 0069-0006-04), 10 x 20 mL vials per carton (NDC 0069-0006-03), Rx only, Distributed by Pfizer Labs; Division of Pfizer Inc., New York, NY 10017.
Lot numbers, UPCs & expiration codes
Lot #: a) 5000983, 5000986, Exp 08/14; 5001023, Exp 09/14; b) 5000927, 5000931, 5000936, 5000942, 06/14; 5001012, 5001040, Exp 09/14; 5001071, Exp 10/14
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-1225-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 14, 2014
- FDA report date
- Apr 16, 2014
- Quantity
- 7919 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Agila Specialties Private Ltd.
Original FDA data
Every field from FDA enforcement report D-1225-2014, exactly as published.
Show all FDA fields
- City
- Bangalore, Karnataka
- Status
- Terminated
- Country
- India
- Event ID
- 67580
- Address
- Sterile Product Division, Opp IIM,
- Address (line 2)
- Bilekahalli, Bannerghatta Road
- Code information
- Lot #: a) 5000983, 5000986, Exp 08/14; 5001023, Exp 09/14; b) 5000927, 5000931, 5000936, 5000942, 06/14; 5001012, 5001040, Exp 09/14; 5001071, Exp 10/14
- Report date
- Apr 16, 2014
- Product type
- Drugs
- Recall number
- D-1225-2014
- Classification
- Class II
- Recalling firm
- Agila Specialties Private Ltd.
- Product quantity
- 7919 cartons
- Termination date
- Dec 3, 2015
- Reason for recall
- Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or expiry date on the outer carton and the potential for illegible/missing lot number and expiry on individual vials.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per carton (NDC 0069-0006-01) and b) 40 mg/20 mL (2 mg/mL) 20 mL Single Dose Vials (NDC 0069-0006-04), 10 x 20 mL vials per carton (NDC 0069-0006-03), Rx only, Distributed by Pfizer Labs; Division of Pfizer Inc., New York, NY 10017.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Feb 14, 2014
- Initial firm notification
- Letter
- Center classification date
- Apr 8, 2014