Why it was recalled
Superpotent Drug: Product contains twice the stated amount of midazolam.
Product description
Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd, Noblesville, Indiana, NDC 45183-0014-69.
Lot numbers, UPCs & expiration codes
Lot #: E1016227C, Exp. 4/21/2014; E0433735C, Exp. 4/20/2014
Where it was sold
IN
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-1362-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 26, 2014
- FDA report date
- Jun 18, 2014
- Quantity
- 80 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmakon Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-1362-2014, exactly as published.
Show all FDA fields
- City
- Noblesville
- State
- IN
- Status
- Terminated
- Country
- United States
- Event ID
- 67903
- Address
- 14450 Getz Rd
- Code information
- Lot #: E1016227C, Exp. 4/21/2014; E0433735C, Exp. 4/20/2014
- Postal code
- 46060-3303
- Report date
- Jun 18, 2014
- Product type
- Drugs
- Recall number
- D-1362-2014
- Classification
- Class I
- Recalling firm
- Pharmakon Pharmaceuticals
- Product quantity
- 80 syringes
- Termination date
- Jul 31, 2014
- Reason for recall
- Superpotent Drug: Product contains twice the stated amount of midazolam.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd, Noblesville, Indiana, NDC 45183-0014-69.
- Distribution pattern
- IN
- Recall initiation date
- Mar 26, 2014
- Initial firm notification
- Telephone
- Center classification date
- Jun 9, 2014