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Recall Observatory FDA recall evidence

Drug product

G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080

D-391-2014

September 30, 2013

Class III

Product summary

Firm
G & W Laboratories Inc
Event
Event 66454
Status
Terminated
Classification
Class III
Quantity
187,368 metal tubes
Official record key
drug-enforcement:D-391-2014

Official wording

Reason: Failed Content Uniformity Specifications; at the 18 month time point.

Code information: 15 gm Lot #: 022211002, 022212001- 022212008, 022212010-022212012, 022212017, 022213001, 022213005, 022213008 60 gm Lot #: 022211002, 022212001- 022212007, 022212009, 022212010, 022212012-022212016, 022212018, 022212019, 022213002.

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Content Uniformity Specifications