notyard
10-01-2009, 03:04 PM
FDA class III recall:
PRODUCT
Prevnar Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM 197 Protein), FOR PEDIATRIC USE ONLY, Disposable Syringe, One Dose (0.5mL) IM NDC 0005-1970-49 (single dose 0.5mL pre-filled syringe), RX only, CONTAINS NO PRESERVATIVE, and carton labeled NDC 0005-1970-50 Wyeth, FOR PEDIATRIC USE ONLY, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM 197 Protein), Prevnar, FOR INTRAMUSCULAR USE ONLY, RX only,10 One Dose (0.5mL)Disposable Syringes and One carton contains 10 single dose (0.5mL) pre-filled syringes. This is shipped 45 cartons of 10 x 1(0.5mL) single dose pre-filled syringes per shipper. Recall # B-1571-09
CODE
Lot D50002
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Inc., Philadelphia, PA, by letter dated July 10, 2009.
Manufacturer: Wyeth Pharmaceuticals, Inc., Pearl River, NY. Firm initiated recall is ongoing.
REASON
Prevnar Pneumococcal 7-valent Conjugate Vaccine, single dose pre-filled syringes not intended for commercial use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
96,280 doses
DISTRIBUTION
Nationwide, North Mariana Islands, Guam and US Virgin Islands
PRODUCT
Prevnar Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM 197 Protein), FOR PEDIATRIC USE ONLY, Disposable Syringe, One Dose (0.5mL) IM NDC 0005-1970-49 (single dose 0.5mL pre-filled syringe), RX only, CONTAINS NO PRESERVATIVE, and carton labeled NDC 0005-1970-50 Wyeth, FOR PEDIATRIC USE ONLY, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM 197 Protein), Prevnar, FOR INTRAMUSCULAR USE ONLY, RX only,10 One Dose (0.5mL)Disposable Syringes and One carton contains 10 single dose (0.5mL) pre-filled syringes. This is shipped 45 cartons of 10 x 1(0.5mL) single dose pre-filled syringes per shipper. Recall # B-1571-09
CODE
Lot D50002
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Inc., Philadelphia, PA, by letter dated July 10, 2009.
Manufacturer: Wyeth Pharmaceuticals, Inc., Pearl River, NY. Firm initiated recall is ongoing.
REASON
Prevnar Pneumococcal 7-valent Conjugate Vaccine, single dose pre-filled syringes not intended for commercial use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
96,280 doses
DISTRIBUTION
Nationwide, North Mariana Islands, Guam and US Virgin Islands