Why it was recalled
Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.
Product description
Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94.
Lot numbers, UPCs & expiration codes
Lot #: 05092016@19, Beyond Use Date: 06/08/16; Discard After 09/01/2017.
Where it was sold
ID
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-1447-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 7, 2016
- FDA report date
- Aug 3, 2016
- Quantity
- 1 bottle
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medicap Pharmacy
Original FDA data
Every field from FDA enforcement report D-1447-2016, exactly as published.
Show all FDA fields
- City
- Meridian
- State
- ID
- Status
- Terminated
- Country
- United States
- Event ID
- 74725
- Address
- 2790 W Cherry Ln Ste 100
- Code information
- Lot #: 05092016@19, Beyond Use Date: 06/08/16; Discard After 09/01/2017.
- Postal code
- 83642-1102
- Report date
- Aug 3, 2016
- Product type
- Drugs
- Recall number
- D-1447-2016
- Classification
- Class II
- Recalling firm
- Medicap Pharmacy
- Product quantity
- 1 bottle
- Termination date
- Aug 8, 2016
- Reason for recall
- Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94.
- Distribution pattern
- ID
- Recall initiation date
- Jul 7, 2016
- Initial firm notification
- Letter
- Center classification date
- Jul 22, 2016