Why it was recalled
Lack of Assurance of Sterility
Product description
Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N 17th St Allentown, PA 610-435-4706, NDC 99999-9019-09
Lot numbers, UPCs & expiration codes
Lot #: 112015, 112715, 113015,120515, 120715, 121215, 121515, 122115, 010516, 010716, 010816, 011116, 012016, 012816, 012916, 020316, 020416, 020516.
Where it was sold
PA
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-0793-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 12, 2016
- FDA report date
- Apr 6, 2016
- Quantity
- 22 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Walter's Pharmacy
Original FDA data
Every field from FDA enforcement report D-0793-2016, exactly as published.
Show all FDA fields
- City
- Allentown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 73336
- Address
- 401 N 17th St
- Code information
- Lot #: 112015, 112715, 113015,120515, 120715, 121215, 121515, 122115, 010516, 010716, 010816, 011116, 012016, 012816, 012916, 020316, 020416, 020516.
- Postal code
- 18104-5034
- Report date
- Apr 6, 2016
- Product type
- Drugs
- Recall number
- D-0793-2016
- Classification
- Class II
- Recalling firm
- Walter's Pharmacy
- Product quantity
- 22 bottles
- Termination date
- Jan 6, 2017
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N 17th St Allentown, PA 610-435-4706, NDC 99999-9019-09
- Distribution pattern
- PA
- Recall initiation date
- Feb 12, 2016
- Initial firm notification
- Telephone
- Center classification date
- Mar 29, 2016