Why it was recalled
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Product description
Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
Lot numbers, UPCs & expiration codes
Lot #: 41652, Expiry: 8/2/14; Lot #: 41668, Expiry: 7/13/14
Where it was sold
MO, TN, MS, WI
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-1257-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 17, 2014
- FDA report date
- May 7, 2014
- Quantity
- 7 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- John W Hollis Inc
Original FDA data
Every field from FDA enforcement report D-1257-2014, exactly as published.
Show all FDA fields
- City
- Nashville
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 67812
- Address
- 110 20th Ave N
- Code information
- Lot #: 41652, Expiry: 8/2/14; Lot #: 41668, Expiry: 7/13/14
- Postal code
- 37203-2315
- Report date
- May 7, 2014
- Product type
- Drugs
- Recall number
- D-1257-2014
- Classification
- Class II
- Recalling firm
- John W Hollis Inc
- Product quantity
- 7 vials
- Termination date
- May 1, 2014
- Reason for recall
- Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
- Distribution pattern
- MO, TN, MS, WI
- Recall initiation date
- Mar 17, 2014
- Initial firm notification
- Telephone
- Center classification date
- Apr 25, 2014