Why it was recalled
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Product description
Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only, Manufactured for H.J. Harkins Company, Inc. dba Pharma Pac by Perrigo Co, Allegan, MI 49010, NDC 52959-0407-01
Lot numbers, UPCs & expiration codes
Lot #: NPD10RP, Exp 08/19; NPD11RP, Exp 09/19; NPD12RP, Exp 11/19; NPD13RP, Exp 02/20; NPD14RP, Exp 02/20; NPD15RP, Exp 05/20; NPD16RP, Exp 06/20; NPD17RP, Exp 01/21; NPD18RP, Exp 02/21
Where it was sold
Distributed in California
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-1580-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 12, 2019
- FDA report date
- Aug 7, 2019
- Quantity
- 97 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- H J Harkins Company Inc dba Pharma Pac
Original FDA data
Every field from FDA enforcement report D-1580-2019, exactly as published.
Show all FDA fields
- City
- Grover Beach
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 83339
- Address
- 1400 W Grand Ave Ste F
- Code information
- Lot #: NPD10RP, Exp 08/19; NPD11RP, Exp 09/19; NPD12RP, Exp 11/19; NPD13RP, Exp 02/20; NPD14RP, Exp 02/20; NPD15RP, Exp 05/20; NPD16RP, Exp 06/20; NPD17RP, Exp 01/21; NPD18RP, Exp 02/21
- Postal code
- 93433-4221
- Report date
- Aug 7, 2019
- Product type
- Drugs
- Recall number
- D-1580-2019
- Classification
- Class II
- Recalling firm
- H J Harkins Company Inc dba Pharma Pac
- Product quantity
- 97 boxes
- Termination date
- Jun 5, 2023
- Reason for recall
- CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only, Manufactured for H.J. Harkins Company, Inc. dba Pharma Pac by Perrigo Co, Allegan, MI 49010, NDC 52959-0407-01
- Distribution pattern
- Distributed in California
- Recall initiation date
- Jul 12, 2019
- Initial firm notification
- Letter
- Center classification date
- Jul 31, 2019