SafetyAlerts
October 3, 2002
Pfizer Has Recalled Benadryl Allergy/Sinus Headache Caplets
(SafetyAlerts)
- The
Food and Drug Administration (FDA) has released the following
information.
PRODUCT
Benadryl Allergy/Sinus Headache Caplets co-packaged with a Bonus 4 mL
bottle of Visine Tears (Diphenhydramine Hydrochloride 12.5 mg,
Pseudoephedrine Hydrochloride 30 mg, Acetaminophen 500 mg), 24 count
package. Recall # D-415-2.
CODES
Codes: Lot Numbers:
01222CD01 Exp Date: 4/2003
01222CM01 "
01322CD01 "
01322CM01 "
01422CN01 "
01522CD01 "
01522CN01 "
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Consumer Healthcare R&D Morris Plains, NJ.,
by letter on June 11, 2002.
Manufacturer: Pfizer, Inc., Vega Baja, PR. Firm initiated recall
ongoing.
REASON
Mispackaged; promotional packages labeled as containing Benadryl
Allergy/Sinus Headache Caplets co-packaged with a bonus 4mL sample of
Visine Tears may actually contain Benadryl Severe Allergy/Sinus Headache
Caplets.
VOLUME OF PRODUCT IN COMMERCE
2270 boxes of 24 caplets.
DISTRIBUTION
AR.
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