Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100
Reported: April 22, 2020 Initiated: April 14, 2020 #D-1244-2020
Product Description
Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100
Reason for Recall
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Details
- Recalling Firm
- B & B Pharmaceuticals, Inc.
- Units Affected
- 3,825 grams
- Distribution
- USA Nationwide
- Location
- Englewood, CO
Frequently Asked Questions
What product was recalled? ▼
Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100. Recalled by B & B Pharmaceuticals, Inc.. Units affected: 3,825 grams.
Why was this product recalled? ▼
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 22, 2020. Severity: Moderate. Recall number: D-1244-2020.
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