Why it was recalled
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Product description
NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 mL) metered spray pump bottle, Distributed by: Medtech Products, Inc., Tarrytown, NY 10591, UPC 8 148332 01101 7.
Lot numbers, UPCs & expiration codes
Lot: 253211, Exp 12/18
Where it was sold
Nationwide in the USA
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-0899-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 6, 2017
- FDA report date
- Jun 21, 2017
- Quantity
- 44,520 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bausch & Lomb, Inc.
Original FDA data
Every field from FDA enforcement report D-0899-2017, exactly as published.
Show all FDA fields
- City
- Tampa
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 77391
- Address
- 8500 Hidden River Pkwy
- Code information
- Lot: 253211, Exp 12/18
- Postal code
- 33637-1014
- Report date
- Jun 21, 2017
- Product type
- Drugs
- Recall number
- D-0899-2017
- Classification
- Class II
- Recalling firm
- Bausch & Lomb, Inc.
- Product quantity
- 44,520 bottles
- Termination date
- May 1, 2019
- Reason for recall
- CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 mL) metered spray pump bottle, Distributed by: Medtech Products, Inc., Tarrytown, NY 10591, UPC 8 148332 01101 7.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 6, 2017
- Initial firm notification
- Letter
- Center classification date
- Jun 9, 2017