Why it was recalled
Superpotent Drug: one ingredient was found to be above assay specification.
Product description
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
Lot numbers, UPCs & expiration codes
Lot #: 110115-2, Exp 01/01/16
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-0802-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 14, 2016
- FDA report date
- Apr 13, 2016
- Quantity
- 1320 vials - all formulas
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Meditech Laboratories, Inc
Original FDA data
Every field from FDA enforcement report D-0802-2016, exactly as published.
Show all FDA fields
- City
- Las Vegas
- State
- NV
- Status
- Terminated
- Country
- United States
- Event ID
- 73537
- Address
- 3200 Polaris Ave Ste 27
- Code information
- Lot #: 110115-2, Exp 01/01/16
- Postal code
- 89102-8379
- Report date
- Apr 13, 2016
- Product type
- Drugs
- Recall number
- D-0802-2016
- Classification
- Class II
- Recalling firm
- Meditech Laboratories, Inc
- Product quantity
- 1320 vials - all formulas
- Termination date
- Jun 7, 2016
- Reason for recall
- Superpotent Drug: one ingredient was found to be above assay specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 14, 2016
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Apr 1, 2016