Why it was recalled
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Product description
Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
Lot numbers, UPCs & expiration codes
Lot #: NW3061,NW3062. Exp. 05/15.
Where it was sold
Nationwide and Puerto Rico.
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-1070-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 9, 2013
- FDA report date
- Feb 12, 2014
- Quantity
- 3,415 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PACK Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-1070-2014, exactly as published.
Show all FDA fields
- City
- Buffalo Grove
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 66595
- Address
- 1110 W Lake Cook Rd
- Address (line 2)
- Ste 301
- Code information
- Lot #: NW3061,NW3062. Exp. 05/15.
- Postal code
- 60089-1944
- Report date
- Feb 12, 2014
- Product type
- Drugs
- Recall number
- D-1070-2014
- Classification
- Class III
- Recalling firm
- PACK Pharmaceuticals, LLC
- Product quantity
- 3,415 bottles
- Termination date
- Apr 11, 2014
- Reason for recall
- Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Sep 9, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 4, 2014