Why it was recalled
Lack of Assurance of Sterility
Product description
Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4022-35
Lot numbers, UPCs & expiration codes
Lot #: RGA 7/19 7/31/2017; RGE 7/19 8/11/2017; RGG7/19 8/11/2017; RGH 7/19 8/17/2017; RHM 8/19 9/14/2017; RJB 10/19 10/23/2017; RJA 10/19 10/23/2017; SCA 3/20 3/22/2018; SIC 9/20 10/9/2018; TAP 1/21 2/26/2019; TDE 4/21 5/30/2019
Where it was sold
U.S.A. 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-0356-2020
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Jul 2, 2019
- FDA report date
- Nov 27, 2019
- Quantity
- 651528 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Altaire Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0356-2020, exactly as published.
Show all FDA fields
- City
- Aquebogue
- State
- NY
- Status
- Completed
- Country
- United States
- Event ID
- 83265
- Address
- 311 W Ln
- Address (line 2)
- PO Box 849
- Code information
- Lot #: RGA 7/19 7/31/2017; RGE 7/19 8/11/2017; RGG7/19 8/11/2017; RGH 7/19 8/17/2017; RHM 8/19 9/14/2017; RJB 10/19 10/23/2017; RJA 10/19 10/23/2017; SCA 3/20 3/22/2018; SIC 9/20 10/9/2018; TAP 1/21 2/26/2019; TDE 4/21 5/30/2019
- Postal code
- 11931-0849
- Report date
- Nov 27, 2019
- Product type
- Drugs
- Recall number
- D-0356-2020
- Classification
- Class II
- Recalling firm
- Altaire Pharmaceuticals, Inc.
- Product quantity
- 651528 units
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4022-35
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Jul 2, 2019
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Nov 15, 2019