Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA…
Reason Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
31 FDA recalls mention Doxycycline. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Doxycycline.
Reason Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
Reason Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Reason Failed dissolution specifications
Reason Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
Reason CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Reason CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Reason Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.
Reason Failed Dissolution Specifications: Out of specification result for the dissolution test.
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications:
Reason Failed Dissolution Specifications:
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical…
Reason CGMP Deviations
Reason Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
Reason Lack of Processing Controls
Reason Labeling: Wrong Bar Code
Reason Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the…
Reason Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the…
Reason Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the…
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