Why it was recalled
CGMP Deviations
Product description
Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007
Lot numbers, UPCs & expiration codes
Gentell Hydrogel AG 2X2 (Gen-11260) Lot #: 1121615, 1121713, 1122215; Exp. 11/18 Gentell Hydrogel AG 4X4 (Gen-11460) Lot #: 1123315, 1125215, 1126515; Exp. 11/18 Gentell Hydrogel AG 4X8 (Gen-11860) Lot #: 1127315, 1130015, 1133615; Exp. 11/18
Where it was sold
United States
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-0242-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 15, 2016
- FDA report date
- Jan 11, 2017
- Quantity
- 3,000 gauzes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Gentell, Inc
Original FDA data
Every field from FDA enforcement report D-0242-2017, exactly as published.
Show all FDA fields
- City
- Bristol
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 75982
- Address
- 2701 Bartram Rd
- Code information
- Gentell Hydrogel AG 2X2 (Gen-11260) Lot #: 1121615, 1121713, 1122215; Exp. 11/18 Gentell Hydrogel AG 4X4 (Gen-11460) Lot #: 1123315, 1125215, 1126515; Exp. 11/18 Gentell Hydrogel AG 4X8 (Gen-11860) Lot #: 1127315, 1130015, 1133615; Exp. 11/18
- Postal code
- 19007-6810
- Report date
- Jan 11, 2017
- Product type
- Drugs
- Recall number
- D-0242-2017
- Classification
- Class II
- Recalling firm
- Gentell, Inc
- Product quantity
- 3,000 gauzes
- Termination date
- Feb 16, 2018
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007
- Distribution pattern
- United States
- Recall initiation date
- Dec 15, 2016
- Initial firm notification
- Center classification date
- Jan 2, 2017